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	11/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6), - 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t, (b)(6), - 200-02-38 - three peg patella 38mm, (b)(6), - 201-78-15 - holding pin mini sharp point 4 pk, (b)(6), - 201-78-81 - 3 trocar, mod.Hex 2pk, (b)(6), - 521-78-23 - threaded pin size 2.3 collared, (b)(6), - 521-78-23 - threaded pin size 2.3 collared, (b)(6), - 521-78-32 - threaded pin size 3.0 collarless, (b)(6), - a10012 - gps implant kit v2.
Event or Problem Description
As reported, approximately 4 years and 3 months post the initial left tka, the patient was revised due to poly wear and femur loosening.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.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear and an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear and femoral loosening could not be determined as the devices were not returned for evaluation, and radiographs were not provided.Correction: d10 concomitant.D10: (b)(6) - 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t.(b)(6) - 201-78-15 - holding pin mini sharp point 4 pk.(b)(6) - 201-78-81 - 3 trocar, mod.Hex 2pk.(b)(6) - 521-78-23 - threaded pin size 2.3 collared.(b)(6) - 521-78-23 - threaded pin size 2.3 collared.(b)(6) - 521-78-32 - threaded pin size 3.0 collarless.(b)(6) - a10012 - gps implant kit v2.

• 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: 19990344
• Report Number: 1038671-2024-02853
• Device Sequence Number: 15568502
• 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: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: 03/01/2020
• 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: 11/03/2023
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2015
• 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.; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male