Its a company with a long history of inventing and distributing many types of orthopedic products including hip, knee, bone cement and bone substitutes. strykers yearend sales for 2016 reached 11.325 billion. stryker hip replacement recalls. the latest stryker recall was in august 2016. stryker issued to surgeons an urgent medical.Consult Now
STRYKER STRYKER BONE CEMENT. Back to Search Results. Catalog Number 6191-1-001. Device Problems Break (1069); Inadequacy of Device Shape and/or Size (1583); Device Slipped (1584) Patient Problems Fall (1848); Pain (1994); Injury (2348); Inadequate Pain Relief (2388) Event Date 10/09/2013. Event Type Injury.
Jun 19, 2020 AccessGUDID - Simplex HV with Gentamicin (04260056885761)- Simplex HV with Gentamicin is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the
Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone cement. || Stryker AutoPlex System kits contain a cement mixer, cement injector, funnel, and an extension tube assembly whereby bone cement powder and liquid monomer are mixed inside a chamber and transferred into a cement injector automatically.
TPLC STRYKER SIMPLEX P BONE CEMENT Back to Search Results Model Number MDM018 Device Problems Loss of or Failure to Bond (1068); Device Slipped (1584) Patient Problem Pain (1994) Event Date
Aug 04, 2020 Orthopaedic cement dispenser A syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down
PMMA bone cement is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone. Contraindications
Dec 15, 2013 2. Historical perspective. Themistokles Gluck (1870), had fixed a total knee prosthesis made of ivory using cement made of plaster and colophony. 3 Otto Rohm and Kulzer were early pioneers who worked extensively on the physical properties and uses of bone cement. The era of modern PMMA bone cements comes from the patent by Degussa and Kulzer
Product Description: The AutoPlex System is used for mixing bone cement and delivering the bone cement percutaneously. For questions regarding this recall, please contact Stryker Instruments: Jennifer Olson 269-389-2644 [email protected] Actions to be
Knee replacement recalls have been issued because of loosening, early wear or faulty packaging. Nearly 1,000 implant parts used in knee surgeries have been affected by Depuy, Zimmer-Biomet and Stryker knee replacement recalls. Drugwatch conducted a separate review in 2018 and identified another 76 recalls.
Mar 29, 2021 According to the agency's database, there were nearly 1,300 recalls on knee replacement systems or components between 2003 and 2019. The companies with the most recalls have also faced significant numbers of lawsuits: Zimmer - 355 recalls. DePuy - 346 recalls. Smith & Nephew - 139 recalls.
Jun 19, 2020 AccessGUDID - Simplex HV (04260056885747)- Simplex HV is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. Simplex HV cement powder also contains insoluble
SIMPLEX HV CEMENT WITH GENTAMICIN - POWDER Page 4 of 13 Date MSDS Created: 16 December, 2014 10.1 Reactivity Powder may form explosive mixture with air. Reaction with acids. 10.2 Chemical stability The product is chemically stable under standard ambient conditions (room temperature) and recommended use.
Stryker Knee Implant Recalls There are around 600,000 total knee replacement surgeries performed in the U.S. each year, and those numbers are increasing year-on-year with an aging population. Medical devices can be tremendously helpful for those with decreased mobility, but can also worsen one’s quality of life if the device is in fact defective.
STRYKER CORPORATION (11) Brand Name. SpinePlex (3) VertaPlex (3) PCD, VertaPlex (2) AutoPlex, VertaPlex (1) BioPrep (1) VertaPlex HV (1) GMDN Term. Orthopaedic cement, non-antimicrobial (11) FDA Product Code Name. CEMENT, BONE, VERTEBROPLASTY (10)
Simplex HV Bone Cement (Stryker/Howmedica) SmartSet HV Bone Cement (DePuy) Symptoms of Bone Cement Failure . Bone cement failure may be difficult to detect given the patient’s medical history dealing with joint pain prior to replacement, pain during the aftermath of surgery, and throughout the rehabilitation process.
SURGICAL SIMPLEX P RADIOPQUE BONE CEMENT - LIQUID Page 1 of 13 MSDS Date Created: 29 October, 2014 1. IDENTIFICATION OF THE MATERIAL AND SUPPLIER 1.1 Product identifier Product name SURGICAL SIMPLEX P LIQUID Synonym(s) STRYKER SIMPLEX P LIQUID 1.2 Uses and uses advised against Use(s) MEDICAL DEVICES 1.3 Details of the
It’s a company with a long history of inventing and distributing many types of orthopedic products including hip, knee, bone cement and bone substitutes. Stryker’s year-end sales for 2016 reached $11.325 billion. Stryker Hip Replacement Recalls. The latest Stryker recall was in August 2016. Stryker issued to surgeons an “Urgent Medical
Jun 01, 2017 Medtronic (NYSE:MDT) is recalling some of its Kyphon instruments that deliver bone cement after discovering a misalignment issue with the devices.. The Fridley, Minn.-based company sent a letter
Product Information. Product Name. Stryker Simplex P Bone Cement with Tobramycin 6197 - 9 - 001. Manufacturer. Stryker. Mfg. Catalog #. 6197-9
Nov 05, 2020 GMDN Preferred Term Name GMDN Definition; Orthopaedic cement preparation/delivery kit A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty).
Jan 29, 2019 SmartSet Bone Cement (DePuy) High viscosity bone cement like Howmedica Simplex cement has been linked with aseptic tibial loosening—loosening of the device with no associated infection. Aseptic loosening can occur due to defective bone cement, such as if the cement fragments or suddenly breaks its bond to the bone. A 2016 bone cement study
Manufacturer: Stryker, DePuy Synthes, DJO Global, and others Active Ingredient(s): Polymethyl methacrylate (PMMA); glass polyalkenoate; or calcium phosphate Description: Bone cement, a material commonly used in joint replacement surgeries, may fragment, causing prosthetics to loosen. Bone cement may also cause a condition known as bone cement implantation
Bone cement is widely used by orthopedic surgeons in joint replacement surgeries — including hip and knee replacements.. Although it is called cement, it does not actually harden like traditional cement. Rather, it is used to fill the space between the implant and the bone-like grout.
Stryker recommends utilizing a cementless implantation of the device during the revisionary hip replacement surgeries. Effectively, as Stryker asserts, the cementless application of the devices allow the bone to knit itself to the implant rather than using the bone cement for adhesion to the femoral head and the hip socket.
Jun 21, 2019 Simplex HV Bone Cement (Stryker/Howmedica) SmartSet HV Bone Cement (DePuy) Lawsuits have already been filed regarding the issue. In 2013, a lawsuit was filed by a woman alleging that the DePuy CMW 1 Gentamicin bone cement used in her knee replacement surgery failed to bond correctly, leading to a loosening of the tibial component.
Oct 27, 2021 Based on the information that has been found since the Class 1 FDA recall, it seems Stryker was aware or should have been aware of many of its medical device. After thoroughly washing the cut segments, acrylic bone cement is applied to the implants and the bone segments. The implants are then fixed to the prepared bed on the bone.
Jun 14, 2016 Recall Status 1: Terminated 3 on March 27, 2017: Recall Number: Z-2536-2016: Recall Event ID: 74582: 510(K)Number: K150582 Product Classification: Cement, bone, vertebroplasty - Product Code NDN:
Jan 11, 2019 According to his lawsuit, Frank underwent knee replacement surgery on Nov. 16, 2015, at Norton Women’s and Children’s Hospital in Louisville, Ky. He was implanted with the DePuy Attune Knee, and the prosthetic was secured to his shin and thigh bones using Stryker’s Simplex Bone Cement, the complaint says.
I have searched for information on bone cement recalls, and contacted several online medical sites trying to find out if there is a recall, but I have not been able to
With over 50 years 10,11,12 of history, 600+ published studies 13 and as the top-selling bone cement in the world, 14 you can trust Stryker and the Simplex family of bone cements for clinically backed fixation, relevant handling and antibiotic choice.