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

Catalog Number	200-74-11
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomittants: (b)(6) 232-03-04 - (disc) optetrak asy, cr porous femoral, sz 4, r.(b)(6) 200-04-44 - (disc) cemented finned t ib.Tra sz 4f/4t.(b)(6) 21-0901-19y-v1 - stryker lpi s7/6/5/4 h.Sierra 90*13/21*1,19.(b)(6) 200-02-29 - rotula tres tetones 29mm.(b)(6) 21-0901-19y-v1 - stryker lpi s7/6/5/4 h.Sierra 90*13/21*1,19.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a 72 yo male patient, who had a right knee implanted, underwent a revision procedure approximately 9 years 2 months post the initial procedure.It was indicated there was premature wear of the polyethelyne, with mechanical loosening of the implant secondary to massive osteolysis.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.X-rays were provided.The explanted devices are not available for return and no device images were provided.No further information.This is 1 of 2 reports for this event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6, h9, h10, h11.No device was returned for evaluation; radiograph images were provided; however, the reported event was able to be confirmed in part.Pre-revision radiographs review identified what appeared to be a gap between the anterior flange of the femoral component and the femoral bone.Additionally, there appears to be lucencies near bone contacting surface and the medial side of the femoral component, as well as the anterior bone contacting surface and medial side of the tibial tray, which is consistent with osteolysis.This indicates that there is femoral loosening and possible tibial loosening.Failure of the cement used to secure the femoral component to the femoral bone, may have led to loosening at the cement-implant and/or cement-bone interface; however, this cannot be confirmed.The gap between the femoral component and the tibial tray appears to be slightly smaller in the pre-revision radiograph compared to the post index radiograph.This may indicate wear of the tibial insert; however, this cannot be confirmed as images of the explanted tibial insert were not provided.A review of complaint history determined that no further action is required as no trends were identified.The reason for the revision reported was likely due to femoral loosening or due to the inclusion of the polyethylene in the packaging recall.This specific tibial insert was packaged for approximately 5.06 years before being implanted.Failure of the cement used to secure the femoral component to the femoral bone, may have led to loosening at the cement-implant and/or cement-bone interface; however, this cannot be confirmed.Prosthesis wear of the tibial insert could not be confirmed from the provided information.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 22459386
• Report Number: 1038671-2025-02452
• Device Sequence Number: 18221539
• Product Code: JWH
• UDI-Device Identifier: 10885862041302
• UDI-Public: 10885862041302
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 11/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2018
• Device Catalogue Number: 200-74-11
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2010
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male