MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++

Model Number	200-72-11
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending engineering evaluation.Concomitant device(s): tibial tray (cn: 200-04-22, sn: (b)(4)).
Event or Problem Description
Tibial tray was loose and poly was worn.Revised to stemmed tibial tray and crc insert.The devices will not be returned for evaluation as the hospital would not allow to be sent out.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the reason for the revision reported was likely the result of an insufficient bond between the tibial tray and the bone, which may have led aseptic (non-infected) tibial loosening.The loosening may have led to an increase in cement and bone particles in the joint space and resulted in prosthesis wear.However, this cannot be confirmed as the explants were not available for evaluation.(d11) concomitant device(s): tibial tray (cn: 200-04-22, sn: (b)(6)).

• Brand Name: OPTETRAK
• Common Device Name: CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9184422
• Report Number: 1038671-2019-00508
• Device Sequence Number: 11695098
• Product Code: JWH
• UDI-Device Identifier: 10885862041227
• UDI-Public: 10885862041227
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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: 03/15/2015
• Device Model Number: 200-72-11
• Device Catalogue Number: 200-72-11
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 04/20/2020
• 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