MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	05/29/2008
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a bilateral knee replacement on (b)(6) 2008.The patient will require a revision surgery for the right knee in the next 12-16 months.The patient has suffered the following injuries and complications: bilateral knee discomfort, paint, restricted motion, stiffness swelling instability, osteolysis, polymeric wear induced synovitis; left knee varus deformity.As a consequence of defects in the aforesaid components, the plaintiff underwent left sided revision surgery on (b)(6) 2023, with removal of the aforesaid components.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
H6.Investigation results - the revision reported was likely the result of prosthesis wear.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear could not be determined as the device was not returned for evaluation, and images and radiographs were not provided.These devices are used for treatments, not diagnosis.There is no other information available.

• Brand Name: OPTETRAK HI-FLEX
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: michael crader ; 3523771140
• MDR Report Key: 17197554
• Report Number: 1038671-2023-01450
• Device Sequence Number: 5768270
• Product Code: JWH
• UDI-Device Identifier: 10885862063991
• UDI-Public: 10885862063991
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2024

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: 12/25/2012
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 244-23-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 02/23/2024; 04/23/2024
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 03/18/2024; 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female