MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-51-5009
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): logic cr femoral por, right, sz 5 02-010-04-0350 5391561.Lgc tibial fit tray cem, sz 5f / 5t 02-012-45-5050 5323546.Three peg patella 41mm, 200-02-41 5698952.
Event or Problem Description
As reported, approximately 4 years post op initial right tka, this 79 y/o male patient was revised due to poly wear and loosening femur.Revised from cr to ps.Patient was last known to be in stable condition following the event.Device is not returning -disposed at the hospital.
Additional Manufacturer Narrative
Section h10: h3: the revision reported was likely the result of both prosthesis wear and femoral loosening.The prosthesis wear may have been the result of malalignment between the femoral and tibial components, instability, patient-related conditions, or any combination of these possibilities, which allowed for increased posterior/medial contact between the femoral component and the tibial insert and led to the observed damage of the polyethylene.Additionally, a contributing factor to the observed damage may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The aseptic (non-infected) femoral loosening may been the result of an insufficient bond between the femoral component and the bone.However, this cannot be confirmed as the devices were not returned for evaluation and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: b1 b2 g2 h4 h6 the revision reported was likely the result of both prosthesis wear and femoral loosening.The prosthesis wear may have been the result of malalignment between the femoral and tibial components, instability, patient-related conditions, or any combination of these possibilities, which allowed for increased posterior/medial contact between the femoral component and the tibial insert and led to the observed damage of the polyethylene.Additionally, a contributing factor to the observed damage may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The aseptic (non-infected) femoral loosening may have been the result of an insufficient bond between the femoral component and the bone.However, this cannot be confirmed as the devices were not returned for evaluation and radiographs were not provided the product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.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 5, 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, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17457433
• Report Number: 1038671-2023-01858
• Device Sequence Number: 7106319
• Product Code: JWH
• UDI-Device Identifier: 10885862230560
• UDI-Public: 10885862230560
• 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: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2021
• Device Catalogue Number: 02-012-51-5009
• 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: 07/16/2023
• Supplement Date Received by Manufacturer: 10/12/2023; 03/25/2025
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 11/01/2023; 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2013
• 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; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male