MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; PS TIBIAL INSERTS SZ 5, 9MM

Model Number	204-25-09
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, the initial implant was on (b)(6) 2011.The patient is a large (b)(6) y/o male, but not obese.On (b)(6) 2019, a revision was completed due to "bad poly".The surgeon opened the knee up to expose well fixed implants and removed the existing 9 mm thick ps tibial insert which showed post wear and minor articular surface wear.After trialing various insert thicknesses, the surgeon chose to place a 10 mm thick ps tibial insert.The patient was stable upon leaving the operating room.Images received.
Additional Manufacturer Narrative
The evaluation noted that the reason for the revision reported was likely due to prosthesis wear is most likely due to a combination of rotational mismatch between the femoral and tibial components and knee instability, resulting in accelerated wear of the tibial insert.However, this cannot be confirmed as the device was not returned for evaluation and no additional patient information was available.

• Brand Name: OPTETRAK
• Common Device Name: PS TIBIAL INSERTS SZ 5, 9MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9670732
• Report Number: 1038671-2020-00034
• Device Sequence Number: 2884935
• Product Code: JWH
• UDI-Device Identifier: 10885862048462
• UDI-Public: 10885862048462
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: 11/09/2015
• Device Model Number: 204-25-09
• Device Catalogue Number: 204-25-09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 04/23/2020
• 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: 63 YR