MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; TRAPEZOID TIBIAL TRAY SZ 3F/2T

Model Number	204-04-32
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device: size 3, 11mm insert optetrak insert (cn: 204-23-11, sn: (b)(4)).
Event or Problem Description
As reported, approximately 7 years postop this (b)(6) male patient¿s right knee, the patient was revised due to the tibial component loosened and the patient had pain in knee.The tibial component was revised.Utilized stemmed tibial component.Femur and patellar components were not revised.Devices not returning, discarded at time of surgery.Patient was last known to be in stable condition following the event.Concomitant device: size 3, 11mm insert optetrak insert (cn: 204-23-11, sn: (b)(4)).
Additional Manufacturer Narrative
Section h10: (h3) the evaluation of the of the revision reported was likely the result of an insufficient bond between the tibial tray and the bone, which led to aseptic (non-infected) tibial loosening.However, this cannot be confirmed because the explants were not returned for evaluation.Concomitant device: size 3, 11mm insert optetrak insert (cn: 204-23-11, sn: (b)(6)).

• Brand Name: OPTETRAK
• Common Device Name: TRAPEZOID TIBIAL TRAY SZ 3F/2T
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11060035
• Report Number: 1038671-2020-00660
• Device Sequence Number: 1265498
• Product Code: JWH
• UDI-Device Identifier: 10885862047656
• UDI-Public: 10885862047656
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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 Model Number: 204-04-32
• Device Catalogue Number: 204-04-32
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR