MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR FEMORAL POR, LEFT, SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-04-0250
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: the revision reported may have been the result of prosthesis wear and femoral loosening.The wear and/or deformation of the tibial insert and patella may have been the result of third body wear, orientation of the components, patient related conditions, instability, or any combination of these possibilities.The loosening may have been the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the femoral component.However, this cannot be confirmed because the components were not returned for evaluation and radiographs were not provided.
Event or Problem Description
As reported, approximately 10 months and 3 days post the previous revision surgery, the patient underwent a second revision due to patella wear and poly wear; there was no change in sizing.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.Associated with 1038671-2023-02948 and 1038671-2024-03169.Previous revision reported under 1038671-2023-00115.

• Brand Name: LOGIC CR FEMORAL POR, LEFT, SZ 5
• 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: 20481110
• Report Number: 1038671-2024-04027
• Device Sequence Number: 8266818
• Product Code: JWH
• UDI-Device Identifier: 10885862158284
• UDI-Public: 10885862158284
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/18/2024

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: 10/22/2024
• Device Catalogue Number: 02-010-04-0250
• 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: 11/23/2023
• Initial Report FDA Received Date: 10/18/2024
• Date Device Manufactured: 10/25/2019
• 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: LGC TIBIAL FIT TRAY CEM SZ.5F / 5T - 02-012-45-505
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 107 KG