MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC CR FEMORAL POR, LEFT, SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-04-0240
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was returned for evaluation; the reported event was confirmed by review of photographs and radiograph images of the device.Operative notes and/or medical records were not provided for review of usage/ technique.The revision reported may have been the result of femoral loosening, prosthesis wear, and osteolysis.The aseptic (non-infected) femoral loosening was likely the result of an insufficient bond between the femoral component and the bone.The polyethylene wear may have been due to malalignment between the implants, high contact stresses during knee flexion, third body wear, instability, patient-related conditions, or any combination of these possibilities.However, this cannot be confirmed as the devices were not available for evaluation.(d10) concomitant devices: (b)(6) - 02-010-04-0240 - logic cr femoral por, left, sz 4 (b)(6) - 02-012-45-4050 - lgc tibial fit tray cem sz 4f / 5t (b)(6) - 02-012-47-4009 - logic cr tib insert std, sz 4, 9mm (b)(6) - 200-02-38 - three peg patella 38mm.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
Approximately 7 years 9 months post the initial left knee implantation, it was reported that a patient underwent a revision procedure.The patient was revised due to femur loosening, osteolysis and poly wear.All components were removed and were replaced by a competitor¿s revision knee.There were no device breakages or surgical delays during the procedure.X-rays were provided.The patient was last known to be in stable condition following the event.No explanted devices are available for analysis.They were disposed of by the hospital.No further information.

• Brand Name: OPTETRAK LOGIC CR FEMORAL POR, LEFT, SZ 4
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20844665
• Report Number: 1038671-2024-04619
• Device Sequence Number: 12748218
• Product Code: JWH
• UDI-Device Identifier: 10885862158277
• UDI-Public: 10885862158277
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

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: 06/06/2020
• Device Catalogue Number: 02-010-04-0240
• 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: 12/04/2024
• Initial Report FDA Received Date: 12/04/2024
• Date Device Manufactured: 06/09/2015
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 90 KG