MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR FEMORAL POR, RIGHT, SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-04-0330
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 1.5 years post op initial right tka, this 60 y/o female patient was revised due to femoral loosening and poly wear.Femur and liner were exchanged.Patient was last known to be in stable condition following the event.Product not returning - disposed at hospital.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): 6751301 - 02-010-04-0330 - logic cr femoral por, right, sz 3.
Additional Manufacturer Narrative
H3: the femoral loosening reported is most likely the result of a weakened biologic integration of the femoral component at the bone-implant interface.There does not appear to be polyethylene wear on the explanted device; however, inclusion of the implanted polyethylene in the packaging recall may also have been a contributing factor to the revision.The failure modes cannot be confirmed as the devices were not available for evaluation and the view on the provided radiograph was inconclusive.
Additional Manufacturer Narrative
*the following sections have corrected information: d1, d4, h4, h6.

• Brand Name: LOGIC CR FEMORAL POR, RIGHT, SZ 3
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653
• MDR Report Key: 18300045
• Report Number: 1038671-2023-02954
• Device Sequence Number: 7152214
• Product Code: JWH
• UDI-Device Identifier: 10885862158369
• UDI-Public: 10885862158369
• 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: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2025
• Device Catalogue Number: 02-010-04-0330
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 02/23/2024; 10/31/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 03/04/2024; 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 71 KG