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	11/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 6095402 02-010-04-0350 - logic cr femoral por, right, sz 5 4998056 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t 6038393 200-02-41 - three peg patella 41mm 6494527 201-78-15 - holding pin mini sharp point 4 pk 6056028 201-78-81 - 3 trocar, mod.Hex 2pk s042636 521-78-23 - threaded pin size 2.3 collared s054282 521-78-23 - threaded pin size 2.3 collared s074791 521-78-32 - threaded pin size 3.0 collarless.
Event or Problem Description
As reported, approximately 3 years post op initial right tka, this male patient was revised due to poly wear and femoral loosening.The tibial insert and femoral component were revised with new components.There was no change in size.Patient was last known to be in stable condition following the event.Unable to obtain x-rays.Product not returning: disposed.
Additional Manufacturer Narrative
(h3) the revision reported may have been the result of femoral loosening and prosthesis wear.The aseptic (non-infected) loosening was likely the result of an insufficient bond between the femoral component and the bone.The tibial insert wear may have been due to possible bony overhang, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed as the devices were not returned for evaluation and radiographs were not provided.

• 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: 20041722
• Report Number: 1038671-2024-03013
• Device Sequence Number: 7955524
• 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: 2020
• 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): 11/06/2024

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: 06/29/2024
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2019
• 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: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male