MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 02-012-35-3511

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 01/15/2024

Event Type  Injury  

Event Description

It was reported via legal documentation that a patient had a left total knee replacement procedure on (b)(6) 2014 and then was revised on (b)(6) 2024.Patient required revision surgery for issues including but not limited to polyethylene prosthesis wear, pain, swelling, instability, osteolysis, and device failure.The most likely cause for the revision reported due to prosthesis 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

D10: concomitant devices: serial number item number and full description (b)(6) a10007 - gps knee implant kit.(b)(6) 02-010-01-0235 - logic femoral ps cem left sz 3.5.(b)(6) 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t.H3: 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: LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19203819
• MDR Text Key: 341294530
• Report Number: 1038671-2024-01004
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862001856
• UDI-Public: 10885862001856
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/29/2024

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 Expiration Date: 12/03/2020
• Device Catalogue Number: 02-012-35-3511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0021-2022
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention