MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 02-012-35-2511

Device Problem Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 08/18/2023

Event Type  Injury  

Event Description

It was reported via legal documentation that a patient had a right total knee arthroplasty on (b)(6) 2015, and then experienced revision surgical procedure on (b)(6) 2023 approximately 8 years and 6 months after initial implant.Op report - postoperative diagnosis ; failed right total knee polyethylene premature wear and failed loose femoral component due to osteolysis from poly wear no images were provided.There is no other information available.

Manufacturer Narrative

D10.Concomitants: 3804182 02-012-35-2509 - logic tibia ps mod insrt sz 2.5 9mm 3719174 02-010-01-0325 - logic femoral ps cem right sz 2.5 3760551 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 2.5t 3832510 200-02-32 - three peg patella 32mm.These devices are used for treatments, not diagnosis.There is no other information available.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 2.5 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
• MDR Report Key: 19131261
• MDR Text Key: 340448607
• Report Number: 1038671-2024-00898
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862001771
• UDI-Public: 10885862001771
• 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: 04/18/2024

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: 07/29/2022
• Device Catalogue Number: 02-012-35-2511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 04/18/2024
• Date Device Manufactured: 07/30/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR