MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 3.5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-51-3509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	09/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 8010018076 a10012 - gps implant kit v2; 4416749 02-010-04-0235 - logic cr femoral por, left, sz 3.5; 5062152 201-78-15 - holding pin mini sharp point 4 pk; 5432691 201-78-81 - 3 trocar, mod.Hex 2pk; 5455021 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t; 5503469 521-78-23 - threaded pin size 2.3 collared; 5592413 200-02-35 - three peg patella 35mm; s004797 521-78-32 - threaded pin size 3.0 collarless; s007598 521-78-23 - threaded pin size 2.3 collared.Recall: 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) 2022 due to poly wear.No breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
H3: the revision reported was performed due to prosthesis wear, as stated in the experience report.However, photographs of the device do not show obvious signs of prosthesis wear or delamination.An additional contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 3.5, 9MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15569382
• Report Number: 1038671-2022-01270
• Device Sequence Number: 6585487
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• 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): 09/17/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2025
• Device Model Number: 02-012-51-3509
• Device Catalogue Number: 02-012-51-3509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 01/11/2023; 07/13/2026; 09/17/2026
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 01/30/2023; 07/13/2026; 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2017
• 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: 56 YR
• Patient Sex: Female