MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD PS TIB BRG 10X87/91MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Fracture (1260)

Patient Problems Adhesion(s) (1695); Failure of Implant (1924); Scar Tissue (2060); Joint Dislocation (2374); Reaction (2414)

Event Date 08/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a right total knee arthroplasty.A year post implantation, the patient underwent separate revisions of the patellar implant and tibial bearing approximately one year later.Approximately 6 years later, the patient then underwent a third revision due to aseptic loosening following a fracture of the poly bearing post.Dense scar tissue and metallosis tissue was removed.The bearing was exchanged without complication.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pre op notes.Pdf, he had a primary knee replacement by dr.Hansen, from then he had a broken poly post treated with revision poly component as well as a fractured patella.Revision post op, right aseptic loosening of tka from poly post fracture with gross subluxation.Spinal and regional, ebl 100ml.Fracture post was immediately visible.This was floating and sitting anteriorly at the knee joint.Dense scar tissue and adhesions removed.Implant bone interfaces debrided with some evidence of metallosis in the tissue.Dense binding scar tissue around the patellar button, patellar component itself well-fixed.Poly revised without complication.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total knee arthroplasty with vague, ill-defined density within the posterior joint space could indicate metallosis.Overall fit alignment of the right total knee arthroplasty is appropriate.Normal bone quality.No signs of right knee implant loosening, radiolucency, or any other contributing factors.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: VNGD PS TIB BRG 10X87/91MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11269232
• MDR Text Key: 230021339
• Report Number: 0001825034-2021-00331
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2011
• Device Model Number: N/A
• Device Catalogue Number: 183680
• Device Lot Number: 099680
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 127