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

Catalog Number	02-012-47-5009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: pending investigation.D10: 3879987 - 02-010-04-0250 - logic cr femoral por, left, sz 5 5828984 - 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t 5893473 - 200-02-38 - three peg patella 38mm 5967715 - 201-78-15 - holding pin mini sharp point 4 pk 4923884 - 201-78-81 - 3 trocar, mod.Hex 2pk s017624 - 521-78-23 - threaded pin size 2.3 collared s017625 - 521-78-23 - threaded pin size 2.3 collared s013348 - 521-78-32 - threaded pin size 3.0 collarless 3042019052 - a10012 - gps implant kit v2 h7: z-0021-2022.
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2019.The patient was revised on (b)(6) 2023 due to poly wear and femur loosening.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear and an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear and femoral loosening could not be determined as the devices were not returned for evaluation, and radiographs were not provided.
Additional Manufacturer Narrative
Correction: h6 clinical code, h6 component code, h6 investigation findings, h6 investigation conclusions.
Additional Manufacturer Narrative
Correction: h6 type of investigation.

• Brand Name: LOGIC CR TIB INSERT STD, 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18197019
• Report Number: 1038671-2023-02852
• Device Sequence Number: 6403438
• 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: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/21/2024

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: 12/19/2025
• Device Catalogue Number: 02-012-47-5009
• 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: 11/03/2023
• Supplement Date Received by Manufacturer: 01/15/2024; 10/31/2024; 11/18/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 01/27/2024; 11/12/2024; 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2017
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male