MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	LOGIC TIB INSERT IMPL CRC, 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	12/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
6095401 02-010-04-0350 - logic cr femoral por, right, sz 5.6497575 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t.6522913 200-02-41 - three peg patella 41mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 61 yo male, initial right knee implanted on (b)(4) 2020, underwent a revision procedure on (b)(6) 2022, approximately 2 years 1 month post the initial procedure.They were revised due to poly wear and pitting being present on the bearing surface.The femur was revised due to loosening.The patient was last known to be in stable condition following the event.The device is available for return.No additional information.
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 aseptic (non-infected) loosening between the porous femoral component and the bone.Prosthesis wear of the tibial insert was also reported but appears minimal in the images provided.However, this cannot be confirmed because the revised components were not returned to exactech for evaluation.An additional contributing factor to the revision may have been inclusion of the tibial insert in the packaging recall.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16064495
• Report Number: 1038671-2022-01636
• Device Sequence Number: 17825851
• Product Code: JWH
• UDI-Device Identifier: 10885862230560
• UDI-Public: 10885862230560
• 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: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2026

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: LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM
• Device Catalogue Number: 02-012-51-5009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 03/27/2023; 05/06/2026
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 03/29/2023; 05/28/2026
• 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
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 101 KG