MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-012-51-4011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this male patient's knee was revised approximately 1 year post op due to poly wear, all implants removed.Patient was last known to be in stable condition following the event.No other patient information/medical history provided.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 3965226, 02-010-03-0240 - logic cr femoral cem, left, sz 4, 4369970, 02-012-45-4050 - lgc tibial fit tray cem sz 4f / 5t, 2899029, 02-012-47-4011 - logic cr tib insert std, sz 4, 11mm, 4243255, 200-02-38 - three peg patella 38mm, 4543407, 201-78-15 - holding pin mini sharp point 4 pk, 4432174, 201-78-81 - 3 trocar, mod.Hex 2pk, 4544512, 201-78-81 - 3 trocar, mod.Hex 2pk, 4544514, 201-78-81 - 3 trocar, mod.Hex 2pk, 4030513, 521-78-23 - threaded pin size 2.3 collared, 4090865, 521-78-23 - threaded pin size 2.3 collared, 4090867, 521-78-23 - threaded pin size 2.3 collared, 3009016002, a10012 - gps implant kit v2.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported may have been due to third body wear, patient-related conditions, instability, and/or malalignment between the femoral and tibial components, which led to prosthesis wear.However, this cannot be confirmed as the devices were not returned for evaluation and images of the explanted devices or pre-revision radiographs were not provided with the complaint submission.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, g2, h6.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 4, 11MM
• 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: 16088246
• Report Number: 1038671-2023-01651
• Device Sequence Number: 16681125
• Product Code: JWH
• UDI-Device Identifier: 10885862230492
• UDI-Public: 10885862230492
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2026

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 Model Number: 02-012-51-4011
• Device Catalogue Number: 02-012-51-4011
• 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: 04/18/2023; 01/21/2026
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 05/09/2023; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Male