MAUDE Adverse Event Report: EXACTECH, INC. UNKNOWN TIBIAL INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	LOGIC CR TIB INSERT STD, SZ 5, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a male patient, initial left knee implanted on (b)(6) 2020, was revised on (b)(6) 2022, approximately 2 years 10 months post the initial procedure due to poly wear.The patient was last known to be in stable condition following the event.The product is not returning as it was disposed of by the hospital.No further information.
Additional Manufacturer Narrative
Concomitants: 6070497 02-010-04-0250 - logic cr femoral por, left, sz 5, unk 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t, unk 200-02-41 - three peg patella 41mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After review of additional information received the following sections, have been updated accordingly: h6: the revision reported was likely the result of tibial insert wear.The cause of the wear could not be determined but may have been due to a combination of third body wear, orientation of the components, and/or patient related conditions.However, this cannot be confirmed because the component was not returned for evaluation and images were not provided.Additionally, the insert was packaged in a non-conforming vacuum bag for five years, which may have contributed to the reported wear.
Event or Problem Description
Right knee revision reported under 1038671-2023-00017.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d1: d4: (remove serial number from initial report-unknown), g2: foreign (australia), h4: remove entry from initial report-unknown), h6: clinical code, component code, types of investigation, investigation findings, investigation conclusions.The revision reported was likely the result of tibial insert wear.The cause of the wear could not be determined but may have been due to a combination of third body wear, orientation of the components, and/or patient related conditions.However, this cannot be confirmed because the component was not returned for evaluation and images were not provided.Additionally, the insert was packaged in a non-conforming vacuum bag for five years, which may have contributed to the reported wear.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: UNKNOWN TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16099073
• Report Number: 1038671-2023-00016
• Device Sequence Number: 6717471
• Product Code: JWH
• UDI-Device Identifier: 10885862174543
• UDI-Public: 10885862174543
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2026

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: 02/03/2023
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 5, 9MM
• Device Catalogue Number: 9999
• 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: 12/12/2022
• Supplement Date Received by Manufacturer: 02/20/2023; 01/21/2026
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 03/13/2023; 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male