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 Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 60 y/o female patient's left knee was revised approximately 2 years post op.Femur and tibia were revised due to osteo-lysis and femoral loosening.Surgeon removed all exactech devices and put another companies product in.Patient was last known to be in stable condition following the event.Product not returning - discarded at the hospital.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 4632315 - 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.6896919 - 200-02-35 - three peg patella 35mm.6176661 - 201-78-15 - holding pin mini sharp point 4 pk.6837191 - 201-78-81 - 3 trocar, mod.Hex 2pk.S337427 - 521-78-23 - threaded pin size 2.3 collared.S337437 - 521-78-23 - threaded pin size 2.3 collared.4579701 - 521-78-32 - threaded pin size 3.0 collarless.9000221286 - a10012 - gps implant kit v2.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of presumed polyethylene wear and an insufficient bond between the femoral component and the bone, which may have led to aseptic (non-infected) femoral loosening.However, the reported femoral loosening could not be confirmed as the devices were not returned for evaluation.

• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20136700
• Report Number: 1038671-2024-03274
• Device Sequence Number: 15303251
• Product Code: JWH
• UDI-Device Identifier: 10885862230324
• UDI-Public: 10885862230324
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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?: Yes
• Operator of Device: Health Professional
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2019
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 103 KG