MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR FEMORAL POR, LEFT, SZ 3.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-04-0235
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
Event or Problem Description
As reported, approximately 4 years post op initial left tka, this 73 y/o female patient was revised due to poly wear and femur loosening.Patient was last known to be in stable condition following the event.Product not returning - disposed.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): (b)(6) - 02-012-45-3525 - lgc tibial fit tray cem sz 3.5f / 2.5t, (b)(6) - 200-02-35 - three peg patella 35mm, (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.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of presumed prosthesis wear of the tibial insert.However, images of the revised insert do not show signs of excessive prosthesis wear inconsistent with being implanted.The aseptic (non-infected) femoral loosening was likely the result of an insufficient bond between the femoral component and the bone.However, this cannot be confirmed because the revised components were not returned for evaluation and no radiographs were provided.

• Brand Name: LOGIC CR FEMORAL POR, LEFT, SZ 3.5
• 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: 20072721
• Report Number: 1038671-2024-03098
• Device Sequence Number: 3074943
• Product Code: JWH
• UDI-Device Identifier: 10885862158260
• UDI-Public: 10885862158260
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: 12/25/2023
• Device Catalogue Number: 02-010-04-0235
• 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: 10/07/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2018
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female