Get the free Medical Device Reports for Metal/Polymer Constrained Hip Prostheses - fda

This document provides a summary of adverse events and medical device reports related to constrained hip prostheses from January 1985 through December 1998, detailing manufacturer, report counts,

How to fill out medical device reports for

How to fill out Medical Device Reports for Metal/Polymer Constrained Hip Prostheses

1. Identify the specific device model and manufacturer.
2. Collect data on the event or issue related to the metal/polymer constrained hip prostheses.
3. Provide patient demographics including age, sex, and any relevant medical history.
4. Describe the nature of the problem, including symptoms, the timeline of events, and any interventions taken.
5. Include details on the device's implantation, such as the date of surgery and any complications encountered.
6. Document all relevant imaging or laboratory results that support the report.
7. Fill out the Medical Device Report form with the gathered information.
8. Submit the completed report to the appropriate regulatory authority, ensuring compliance with deadlines and reporting requirements.

Who needs Medical Device Reports for Metal/Polymer Constrained Hip Prostheses?

1. Healthcare providers involved in the surgical implantation of metal/polymer constrained hip prostheses.
2. Patients who have experienced adverse events or complications using these devices.
3. Manufacturers of hip prostheses who are required to monitor device performance and safety.
4. Regulatory agencies that oversee medical device safety and efficacy.

People Also Ask about

What are the symptoms of a recalled hip replacement?

DePuy and Zimmer Hip Replacement Recall Pain in hip, thigh or groin; swelling; suffering from pain while walking; pain while bearing weight or even rising from a seated position; discomfort caused by grinding between the ball and socket; bone loss caused by inflammation and reduced range of motion.

What hip implant manufacturer is in a lawsuit?

Zimmer Biomet CPT® Hip System devices may increase the risk of femur fractures. Many patients don't feel they were warned of this risk. If you received this implant and later suffered a broken thigh bone, you may be eligible for compensation from a Zimmer Biomet hip replacement lawsuit.

What metal on metal hip replacements have been recalled?

Beginning of Issues with Replacements In 2010, the DePuy ASR (DASR) was the first metal on metal hip replacement to be recalled. In 2013, there was a large settlement with many who had ASR implants and undergone a revision surgery. There is another type of implant called the Biomet Magnum M2A.

What metal is most commonly used in hip replacements?

Cobalt-chrome is the most commonly used metal for hip implants. Titanium is also used but is a softer metal with similar properties to bone. While stainless steel has been used in the past, nowadays it is only used to repair fractured hips. This is because it's too soft to be used as the primary metal of an implant.

What is the best hip joint implant?

Ceramics. Ceramic is arguably the best material for hip replacement surgeries where strength, hardness and resistance are important. Its physical and chemical properties help reduce wear and tear often observed with polyethylene and metal, ultimately resulting in better longevity for artificial hips.

What is the controversy with metal on metal hip implants?

Health Problems from Metal Ions: Metal-on-metal hips have raised other concerns, including potential harm from cobalt and chromium ions released into the bloodstream. These are associated with a range of potential health problems including cancer, neurological difficulties and thyroid and heart disease.

Which hip implants have been recalled?

Some titanium hip replacement devices have been known to cause problems. This includes Stryker's Accolade TMZF, Rejuvenate and ABG II hip implants, all of which have been recalled. Many non-titanium hip implant devices are known to cause problems as well.

What brand of hip replacement is being recalled?

In August 2022, Exactech expanded the hip replacement device recall to include all hip devices with polyethylene components packaged in defective bags. The FDA classified these as a Class II recall on September 9, 2022.

For pdfFiller’s FAQs

What is Medical Device Reports for Metal/Polymer Constrained Hip Prostheses?

Medical Device Reports (MDRs) for Metal/Polymer Constrained Hip Prostheses are regulatory documents required by the FDA that provide information about adverse events and device failures associated with these specific hip implants.

Who is required to file Medical Device Reports for Metal/Polymer Constrained Hip Prostheses?

Manufacturers, importers, and user facilities are required to file Medical Device Reports for Metal/Polymer Constrained Hip Prostheses when they become aware of adverse events related to these devices.

How to fill out Medical Device Reports for Metal/Polymer Constrained Hip Prostheses?

To fill out Medical Device Reports for Metal/Polymer Constrained Hip Prostheses, complete the appropriate forms using data such as device identification, patient information, a description of the adverse event, and any relevant medical history.

What is the purpose of Medical Device Reports for Metal/Polymer Constrained Hip Prostheses?

The purpose of Medical Device Reports for Metal/Polymer Constrained Hip Prostheses is to monitor the safety and effectiveness of these devices, identify potential safety issues, and inform regulatory decision-making.

What information must be reported on Medical Device Reports for Metal/Polymer Constrained Hip Prostheses?

Information that must be reported includes the device details (name, model, manufacturer), patient demographics (age, sex), event details (type of adverse event, outcome), and any additional relevant clinical information.