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

Catalog Number	02-010-04-0350
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant devices: logic cr femoral por, right, sz 5 02-010-04-0350, (b)(6); lgc tibial fit tray cem sz 5f / 5t 02-012-45-5050, (b)(6); three peg patella 41mm 200-02-41, (b)(6).H3: the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
As reported, approximately 4 years post op initial right tka, this 79 y/o male patient was revised due to poly wear and loosening femur.Revised from cr to ps.Patient was last known to be in stable condition following the event.Device is not returning -disposed at the hospital.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of both prosthesis wear and femoral loosening.The prosthesis wear may have been the result of malalignment between the femoral and tibial components, instability, patient-related conditions, or any combination of these possibilities, which allowed for increased posterior/medial contact between the femoral component and the tibial insert and led to the observed damage of the polyethylene.Additionally, a contributing factor to the observed damage may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The aseptic (non-infected) femoral loosening may have been the result of an insufficient bond between the femoral component and the bone.However, this cannot be confirmed as the devices were not returned for evaluation and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CR FEMORAL POR, RIGHT, 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21561041
• Report Number: 1038671-2025-01512
• Device Sequence Number: 17236703
• Product Code: JWH
• UDI-Device Identifier: 10885862158406
• UDI-Public: 10885862158406
• 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: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: 04/19/2023
• Device Catalogue Number: 02-010-04-0350
• 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: 07/16/2023
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2018
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male