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

Catalog Number	202-04-32
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	11/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 200-03-29 - 1/ 29 mm: (b)(6).232-03-03 - cr, ak r-3: (b)(6).Tn190-119-05 - m-class 19x1.19x105: (b)(6).Tn193-119-90 - m-class 19/13x 1.19x90 mm: (b)(6).Z99005 - tka: unassigned zbatt-01: unassigned zoscl-01: unassigned zream-01: unassigned.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
As reported, in 2021 a sales rep informed us that there is a plan that the recall insert will be retrieved at revision surgery around week after next due to posterior wear of the insert.In (b)(6) 2026 the revision occurred.The patient who had a right tka using a cr slope+ tibial insert complained of knee swelling and pain.The surgeon diagnosed the wear of the tibial insert.The revision surgery for the replacement of the tibial insert was performed.Breakage and wear were observed in the retrieved tibial insert as well as tibial tray.The surgeon decided that the insert and tibial tray only were replaced with a new crc size 3 13 mm neutral insert and tibial tray 3f/2t.There was device breakage, which was retrieved from the wound site.Polyethylene particles were removed by the surgeon appropriately.There were no surgical delays reported.The patient was last known to be in stable condition following the event.No x-rays were provided.The explanted devices are not available for return.Device images were provided.No further information.This is 1 of 2 reports.

• Brand Name: OPTETRAK
• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24643082
• Report Number: 1038671-2026-00303
• Device Sequence Number: 18588423
• Product Code: JWH
• UDI-Device Identifier: 10885862046789
• UDI-Public: 10885862046789
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K936079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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: 09/27/2021
• Device Catalogue Number: 202-04-32
• 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: 03/11/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2016
• 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; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 100 KG