MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; CR TIBIAL INSERT SZ 1, 9MM

Model Number	CR TIBIAL INSERT SZ 1, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Cemented finned tibial tray size 2f/1t - (cn: 200-04-21, sn: (b)(4)).Optetrak asy, cr cemented femoral, size - (cn: 230-02-01, sn: (b)(4)).
Event or Problem Description
As reported, approximately 5 years postop a left tka on this male patient, a revision was completed.During the procedure, the surgeon reports that there was tissue necrosis.The devices will be returned for analysis.
Additional Manufacturer Narrative
Section h10: h3: the evaluation of the of the reported event was likely the result of rotational mismatch between the femoral component and the tibial components and patient¿s compromised soft tissue envelop, which led to severe joint instability, posterior articulation of the femoral component, and extensive wear of both the tibial insert and tibial tray.The instable joint resulted in excessive motion and loads to the plastic and metal prostheses and premature damage to the polyethylene tibial insert.Metal debris was generated from metal-on-metal contact of the femoral component and the tibial tray, leading to the reported tissue necrosis.

• Brand Name: OPTETRAK
• Common Device Name: CR TIBIAL INSERT SZ 1, 9MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10972466
• Report Number: 1038671-2020-00643
• Device Sequence Number: 11832988
• Product Code: JWH
• UDI-Device Identifier: 10885862040145
• UDI-Public: 10885862040145
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

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 Expiration Date: 11/20/2015
• Device Model Number: CR TIBIAL INSERT SZ 1, 9MM
• Device Catalogue Number: 200-21-09
• Device Lot Number: 1120799
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 09/07/2021
• 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