MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-47-3013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 02-010-03-0230 - logic cr femoral cem, left, sz 3, (b)(6), 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t, (b)(6), 200-02-29 - three peg patella 29mm.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.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case: usa.Patient id: (b)(6) + left knee.Case: (b)(4) is associated with this case.It was reported that approximately 97 months after a left total knee replacement procedure, the patient has experienced prosthesis wear.No further issues or complications were reported.No additional information is available." legal case: usa.Patient id: (b)(6) + left knee.Case: (b)(4) is associated with this case.During the review of case: (b)(4), it was discovered that the patient underwent an index left total knee procedure on (b)(6) 2016.No allegations have been made against this device.No additional information is available.The serial number: (b)(6) is confirmed to be a part of recall number: z-0021-2022 02-012-47-3013 - logic cr tib insert std, sz 3,13mm.Serial: (b)(6), 510k: k111400, udi: (b)(4), product code: jwh, x-ray: no, operative notes: no.Concomitant devices: (b)(6), 02-010-03-0230 - logic cr femoral cem, left, sz 3, (b)(6), 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t, (b)(6), 200-02-29 - three peg patella 29mm.
Additional Manufacturer Narrative
The prosthesis wear reported cannot be confirmed and potential contributions to user or patient-related considerations cannot be assessed as the device remains implanted and no photos or radiographs were provided.Additionally, the insert was packaged in a non-conforming vacuum bag for over five years, which may have contributed to the reported wear.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 3, 13MM
• 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: 20712266
• Report Number: 1038671-2024-04418
• Device Sequence Number: 9783285
• Product Code: JWH
• UDI-Device Identifier: 10885862174369
• UDI-Public: 10885862174369
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

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: 08/02/2019
• Device Catalogue Number: 02-012-47-3013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 04/16/2025
• Date Device Manufactured: 08/02/2011
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 87 YR
• Patient Sex: Female