MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	10/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
Per a report from the legal department the patient had an initial right knee replacement on (b)(6) 2007.Approximately 9 years and 5 months after the initial procedure the patient had a right knee revision on (b)(6) 2016 due to worsening pain and swelling.In or about 2016, imaging demonstrated interval subsidence of the tibial component consistent with loosening of the component.During the revision surgery, the patient's orthopedic surgeon stated that there was osteolysis noted at the distal femur on the lateral condyle and the tibial component was grossly loose.Pathology confirmed that there was a tissue reaction to the polyethylene.Upon information and belief, the loose components and osteolysis were due to premature polyethylene wear of the tibial insert.There is no other patient demographic or medical history available.There is no information on the 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
H3: investigation results - the revision reported was likely the result of pain, subsidence and loosening of the tibial tray, loosening of the femoral component, and prosthesis wear of the tibial insert.However, the underlying cause(s) and sequence of events cannot be determined because no operative notes, images, or radiographs were provided, and the revised components were not returned to exactech for evaluation.

• Brand Name: OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 9MM
• 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: miguel sosa ; 3523771140
• MDR Report Key: 16814359
• Report Number: 1038671-2023-00833
• Device Sequence Number: 20256950
• Product Code: JWH
• 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: 2007
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/25/2011
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 244-24-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 12/20/2023; 09/15/2026
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 12/20/2023; 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2006
• 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: A
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown