MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE 3 8 MM HEIGHT FEMORAL SIZE A,B,C,D,E,F,G; PROSTHESIS, KNEE

Model Number N/A

Device Problems Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Information (3190)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Around 10 years ago.Concomitant medical products: unknown zimmer unicompartmental knee femoral, catalog#: ni, lot#: ni; unknown zimmer unicompartmental knee tibial tray, catalog#: ni, lot#: ni.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that patient underwent partial knee arthroplasty.Subsequently, the patient was revised due to loosening approximately ten years post implantation.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of articular surface lot 60789958 identified nicks, gouges and extreme wear.An additional analysis was performed by the research team and noted the implant showed wear and deformation along the worn path.Additionally, there was delamination on the edges of the worn path due to oxidation in the material.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that patient underwent partial knee arthroplasty.Subsequently, the patient was revised due to implant wear approximately ten years post implantation.

• Brand Name: ARTICULAR SURFACE SIZE 3 8 MM HEIGHT FEMORAL SIZE A,B,C,D,E,F,G
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7906590
• MDR Text Key: 121620145
• Report Number: 0001822565-2018-05238
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: PK033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: N/A
• Device Catalogue Number: 00584202308
• Device Lot Number: 60789958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2019
• 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 Age: 88 YR
• Patient Weight: 50