MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 5,

Model Number	234-03-05
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
Male, age (b)(6), weight unknown, initial implant of right knee on (b)(6) 2013.Upon exposure of the knee joint, it was found that the femur was loose and could be removed by hand.Patient was last known to be in stable condition following the event.Device not returning due to the hospital won't release implants.Concomitant medical products: optetrak tibial tray (cn: 200-04-55, (b)(4)).Optetrak tibial insert (cn: 204-25-11, (b)(4)).
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted in the revision reported was likely the result of an insufficient bond between the implant and the bone, which led to aseptic (non-infected) femoral loosening.However, this cannot be confirmed as the devices were not available for evaluation.Section(s): no information has been provided: a4, a5, and b6.The following section(s) have additional info; g4, g5, g7, h1, h2, h3, and h7.

• Brand Name: OPTETRAK
• Common Device Name: OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 5,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10298969
• Report Number: 1038671-2020-00356
• Device Sequence Number: 19697634
• Product Code: JWH
• UDI-Device Identifier: 10885862063281
• UDI-Public: 10885862063281
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 11/13/2013
• Device Model Number: 234-03-05
• Device Catalogue Number: 234-03-05
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR