MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; CR TIBIAL INSERT SZ 4, 11MM, SLOPE ++

Model Number	200-74-11
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Date of Event	09/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending engineering evaluation.
Event or Problem Description
Polyethylene exchange.
Event or Problem Description
As reported, this 69 y/o male patient with average build, was initial implanted with a tka on (b)(6) 2012 and experienced a left knee revision due to polyethylene due to wear and instability on (b)(6) 2019.The patient is recovering well.The devices will not be returned due to hospital policy.No other information available.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the reason for the revision reported was likely the result of prosthesis wear and instability.However, this cannot be confirmed as the device was not available for evaluation and no further information was provided.No information provided in the following section(s): a4, a5, b6, and b7.The following section(s) have additional info: a3, b5, g4, g7, h1, h2, h3, and h7.Section h11: corrections made in the following section(s): (f6) and (f8) were entered in error, please disregard.

• Brand Name: OPTETRAK
• Common Device Name: CR TIBIAL INSERT SZ 4, 11MM, SLOPE ++
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9195309
• Report Number: 1038671-2019-00517
• Device Sequence Number: 2589702
• Product Code: JWH
• UDI-Device Identifier: 10885862041302
• UDI-Public: 10885862041302
• 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 Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 07/13/2014
• Device Model Number: 200-74-11
• Device Catalogue Number: 200-74-11
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/26/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 04/15/2020
• 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
• Patient Age: 69 YR