MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 2, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-51-2013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial right total knee arthroplasty (tka) on (b)(6) 2020.The patient was revised on (b)(6) 2023 due to femoral loosening and poly wear on the patella, which resulted in instability.All components were revised.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.Associated with 1038671-2023-02914 and 1038671-2024-03158.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of femoral loosening, prosthesis wear, and instability.The aseptic (non-infected) loosening was likely the result of an insufficient bond between the femoral component and the bone.Although the sequence of events cannot be confirmed, the loosening may have contributed to the reported joint instability.The wear may have been due to orientation of the components, third body wear, and/or the reported joint instability.However, this cannot be confirmed as the devices were not returned for evaluation and radiographs were not provided.D10: lgc tibial fit tray cem sz 2f / 2t - 2-012-45-2020 - 5507506.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 2, 13MM
• 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: 20560033
• Report Number: 1038671-2024-04171
• Device Sequence Number: 3102832
• Product Code: JWH
• UDI-Device Identifier: 10885862230348
• UDI-Public: 10885862230348
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

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 Expiration Date: 07/09/2026
• Device Catalogue Number: 02-012-51-2013
• 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: 11/17/2023
• Initial Report FDA Received Date: 10/29/2024
• Date Device Manufactured: 07/10/2018
• 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 Sex: Female