MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-51-2009
Medical Device Problem Codes	Naturally Worn (2988); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	06/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): (b)(6), a10012 - gps implant kit v2; (b)(6), 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t; (b)(6), 02-010-04-0220 - logic cr femoral por, left, sz 2; (b)(6), 201-78-81 - 3 trocar, mod.Hex 2pk; (b)(6), 200-02-32 - three peg patella 32mm; (b)(6), 201-78-15 - holding pin mini sharp point 4 pk; (b)(6), 521-78-32 - threaded pin size 3.0 collarless; (b)(6), 521-78-23 - threaded pin size 2.3 collared; (b)(6), 521-78-23 - threaded pin size 2.3 collared.
Event or Problem Description
It was reported that a patient from australia has been scheduled for left tka revision surgery.Revision has not yet occurred.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of presumed prosthesis wear of the tibial insert and patella component.However, images of the revised components do not show signs of excessive prosthesis wear inconsistent with being implanted, no radiographs were provided, and the revised component was not returned to exactech for evaluation.Section h11: *the following sections have corrected information: (b4) describe event or problem: as reported, approximately 2 years post op initial left tka, this 70 y/o female patient was revised due to poly wear.Patella and liner were exchanged.Patient was last known to be in stable condition following the event.Device is not returning - disposed at the hospital.(h6) component code: 734, bearings.
Event or Problem Description
As reported, approximately 2 years post op initial left tka, this 70 y/o female patient was revised due to poly wear.Patella and liner were exchanged.Patient was last known to be in stable condition following the event.Device is not returning - disposed at the hospital.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: b1, b2, b3, d6b, d8, g2 (correct initial report-australia), h6: clinical code, medical device problem code, types of investigation, investigation findings, investigation conclusions.The revision reported was likely the result of presumed prosthesis wear of the tibial insert and patella component.However, images of the revised components do not show signs of excessive prosthesis wear inconsistent with being implanted, no radiographs were provided, and the revised component was not returned to exactech for evaluation 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 2, 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: 17215636
• Report Number: 1038671-2023-01482
• Device Sequence Number: 3022177
• Product Code: JWH
• UDI-Device Identifier: 10885862230324
• UDI-Public: 10885862230324
• 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: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2026

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: 08/23/2026
• Device Catalogue Number: 02-012-51-2009
• 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: 06/07/2023
• Supplement Date Received by Manufacturer: 09/18/2023; 01/16/2026
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 10/11/2023; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2018
• 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; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Unknown