MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-51-4009
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Joint Laxity (4526)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation.
Event or Problem Description
This patient presented to surgeons office complaining about their knee.The patient reported pain, instability, and dissatisfaction.The patient has recalled tibial poly inserts in both knees.The osteolysis is shown to be worse on the left knee x-ray, so the patient was scheduled for a left full knee revision vs poly swap.Revision has not yet occurred.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.D10: concomitant devices: 02-012-45-4050 - lgc tibial fit tray cem sz 4f / 5t 4412232 200-02-32 - three peg patella 32mm 6500540 h3: the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that this patient's right knee was revised approximately 4 years 6 months post initial operation.The patient reported pain, instability, and dissatisfaction.The patient has recalled a tibial poly insert.The patient underwent a right knee revision, a femoral component revision, and a poly revision was performed due to knee instability.The patient was revised to femoral cc revision component and psc poly implant.The surgeon wanted to upsize the femur component for sizing and to close the extension gap knowing it is off-label when keeping the current tibia implant size.The tibia component was well fixed, and the surgeon trailed the revision sizes.The surgeon was happy with the articulation and stability.The patient was implanted with the cc revision femoral component and new psc poly.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, h6.Mdr section codes updated/corrected: b, c, d.The revision reported was likely the result of the reported pain and instability.Additional reasons for the reported revision may be 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 relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM
• 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: 20397075
• Report Number: 1038671-2024-03848
• Device Sequence Number: 6261656
• Product Code: JWH
• UDI-Device Identifier: 10885862230485
• UDI-Public: 10885862230485
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2025

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: 09/06/2024
• Device Catalogue Number: 02-012-51-4009
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 01/11/2025; 06/25/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 01/29/2025; 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2016
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male