MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-51-5011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: the revision reported was likely the result of a weakened biologic integration of the femoral component at the bone-implant interface which led to aseptic (non-infected) femoral loosening.The image of the tibial insert showed minor third body wear but was largely unremarkable for an implanted device with no evidence of volumetric wear.Localized damage was noted on the patella likely secondary to high in-vivo pressure from insufficient superior patellar resection.However, the extent and root cause of the prosthesis wear, osteolysis, and femoral loosening could not be determined as the devices were not returned for evaluation.D10: (b)(6), 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t, (b)(6), 201-78-15 - holding pin mini sharp point 4 pk, (b)(6), 201-78-81 - 3 trocar, mod.Hex 2pk, (b)(6), 521-78-23 - threaded pin size 2.3 collared, (b)(6), 521-78-23 - threaded pin size 2.3 collared, (b)(6), 521-78-32 - threaded pin size 3.0 collarless.
Event or Problem Description
As reported, approximately two years post the initial left total knee arthroplasty, the patient was revised due to patella wear and delamination.The tibial insert and femoral component were also exchanged.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 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 ; 3523771140
• MDR Report Key: 22063825
• Report Number: 1038671-2025-02111
• Device Sequence Number: 12725078
• Product Code: JWH
• UDI-Device Identifier: 10885862230577
• UDI-Public: 10885862230577
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2026
• Device Catalogue Number: 02-012-51-5011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2023
• Initial Report FDA Received Date: 05/21/2025
• Date Device Manufactured: 05/18/2018
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male
• Patient Weight: 92 KG