MAUDE Adverse Event Report: EXACTECH, INC. KNEE COMPONENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 9999

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 03/22/2023

Event Type  Injury  

Event Description

It was reported via legal documentation that a patient had a right total knee replacement procedure on (b)(6) 2015 and then was revised on (b)(6) 2023.Patient required revision surgery for issues including but not limited to pain, swelling, instability, and polyethylene wear.The mostly likely cause for the revision reported due to prothesis wear is a combination of risk factors including use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.

Manufacturer Narrative

The revision reported was likely the result of prosthesis wear of the tibial insert.The cause of prosthesis wear is generally a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.

• Brand Name: KNEE COMPONENT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19194934
• MDR Text Key: 341179941
• Report Number: 1038671-2024-00995
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9999
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention