MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-4011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	08/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D1 concomitants: (b)(6) 02-010-01-0340 - femur ps cem.Nº4 der.(b)(6) 02-012-45-4030 - bandeja tibial logic fit 4f/3t.H3: the revision reported was likely the result of a combination of prosthesis wear and aseptic loosening between the femoral component and the bone.The loosening may have led to an increase in cement and bone particles in the joint space and resulted in prosthesis wear or prosthesis wear may have contributed to particle-induced osteolysis.However, the contributions of patient conditions, loosening and prosthesis wear to the sequence of events cannot be determined as the devices were not available for evaluation and radiographs and photographs were not provided.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.
Event or Problem Description
As reported, this patient was implanted with a total knee arthroplasty (tka).The patient was revised due to polyethylene wear.Patient had a loose femur with osteolytic cavities and posterior tibial defect.Revised to competitors device.No additional details are available at this time.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 4 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22306372
• Report Number: 1038671-2025-02334
• Device Sequence Number: 18163098
• Product Code: JWH
• UDI-Device Identifier: 10885862001894
• UDI-Public: 10885862001894
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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: 01/03/2022
• Device Catalogue Number: 02-012-35-4011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 06/23/2025
• Date Device Manufactured: 01/08/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 113 KG