MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 2,; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	230-03-02
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	11/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Informed to exchange insert by hospital, after about 7 years later from a primary surgery.The patient who had total knee arthroplasty using cr slope ++ tibial insert complained knee swelling and pain, the surgeon diagnosed the wear of the tibial insert, then revision surgery for the replacement of the tibial insert was performed.Breakage and wear was observed in the retrieved tibial insert.Also, he found out metallosis.He decided that no problem of locking mechanism of the tibial tray was found, and removing all proliferative tissues, the insert only was replaced to new one.
Additional Manufacturer Narrative
Multiple reports were filed for this event, please see associated reports: 1038671-2022-01594.The revision reported was likely due to progressive prosthesis wear over 7 years of implantation secondary to mechanical overload on the posterior medial edge of the tibial insert leading to full thickness polyethylene wear and metallic wear of the tibial tray and/or femoral component.Contributions from overall slope of the insert and tibial tray, rotational malalignment and/or soft tissue instability may have allowed for excessive posterior contact leading to wear and possible fracture of the polyethylene insert.However, the contributions of individual factors or a combination of the aforementioned factors cannot be confirmed as the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly,.

• Brand Name: OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 2,
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22374771
• Report Number: 1038671-2025-02396
• Device Sequence Number: 19949082
• Product Code: JWH
• UDI-Device Identifier: 10885862061744
• UDI-Public: 10885862061744
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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: 04/14/2020
• Device Catalogue Number: 230-03-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 07/01/2025
• Date Device Manufactured: 04/17/2015
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 70 KG