MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; CR TIBIAL INSERT SZ4, 9MM

Model Number	232-03-04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical devices: (cn: 200-24-09, sn: (b)(4)) cr tibial insert size 4, 9mm.(cn: 200-04-44, sn: (b)(4)) cemented finned tray 4f/4tt.
Event or Problem Description
As reported, approximately 7 years postop the initial right tka, this (b)(6) y/o male patient experienced severe instability through range of motion.During the operation there was noticeable osteolysis present, bacterial swabs and tissue samples were collected and sent to pathology.Noticeable distal and posterior bone loss was seen on the lateral side of the femur.Patients own bone, bone cement and augments were used to repair femoral defects.The polyethylene insert was destroyed especially on the posterior- lateral side.Devices are to return.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the event was likely the result of joint instability and prosthesis wear.The instability may have been due to patient conditions, an alignment issue of the implants, and/or wear of the insert.The prosthesis wear was likely the result of third body wear, delamination, and/or rotational mismatch between the femoral and tibial components.Concomitant device: (cn: 232-03-04 sn: (b)(6)) optetrak asy, cr porous femoral, sz 4, right.(cn: 200-04-44, sn: (b)(6)) cemented finned tray 4f/4t.

• Brand Name: OPTETRAK
• Common Device Name: CR TIBIAL INSERT SZ4, 9MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10612764
• Report Number: 1038671-2020-00558
• Device Sequence Number: 2604775
• Product Code: JWH
• UDI-Device Identifier: 10885862063113
• UDI-Public: 10885862063113
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

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: 06/16/2016
• Device Model Number: 232-03-04
• Device Catalogue Number: 200-24-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 12/18/2020
• 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: 81 YR