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

Catalog Number	02-012-51-5009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately three years and 3 months post the initial right total knee arthroplasty (tka), the patient was revised due to femur loosening, osteolysis and poly wear.Everything was removed and exchanged to a competitor's product.There was no reported breakage of a 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
D10: 5748958 - 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t 6630575 - 200-02-38 - three peg patella 38mm 6712288 - 201-78-15 - holding pin mini sharp point 4 pk 6743595 - 201-78-81 - 3 trocar, mod.Hex 2pk s103827 - 521-78-23 - threaded pin size 2.3 collared s125834 521-78-23 - threaded pin size 2.3 collared 5499019 521-78-32 - threaded pin size 3.0 collarless 9018920083 a10012 - gps implant kit v2 h3: the revision reported may have been the result of femoral loosening, osteolysis, and prosthesis wear.The aseptic (non-infected) femoral loosening was likely the result of an insufficient bond between the femoral component and the bone.Based on the images provided, there does not appear to be an excessive amount of wear on the articular surface of the insert.The deformation and/or wear does not appear inconsistent with being implanted.However, this cannot be confirmed because the devices were not returned for evaluation.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 5, 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20576766
• Report Number: 1038671-2024-04195
• Device Sequence Number: 8508360
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2024

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: 02-012-51-5009
• 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: 03/21/2024
• Initial Report FDA Received Date: 10/31/2024
• Date Device Manufactured: 01/05/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 90 KG