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
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: (b)(6) 203-96-22 - (11-3110) 2000 90x19x 1.19mm (b)(6) 200-02-35 - three peg patella 35mm (b)(6) 02-010-01-0325 - logic femoral ps cem right sz 2.5 (b)(6) 2-012-45-2515 - lgc tibial fit tray cem sz 2.5f / 1.5t (b)(6) 203-96-21 - (11-2714) 2000 90x13/21x 1.9mm.
Event or Problem Description
Legal case ¿ usa ((b)(4)).(b)(4) lk rev is associated with this case.It was reported via legal documentation that approximately 98 months after a right total knee replacement procedure, the patient has experienced prosthesis wear.The right knee is unrevised at this time.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
The reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear and/or inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM
• Common Device Name: 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20429732
• Report Number: 1038671-2024-03950
• Device Sequence Number: 7627359
• Product Code: JWH
• UDI-Device Identifier: 10885862001771
• UDI-Public: 10885862001771
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2024
• Device Catalogue Number: 02-012-35-2511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 05/14/2025
• Date Device Manufactured: 03/03/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Unknown