MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY, CR POROUS FEMORAL, SZ 3, RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	232-03-03
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Metal Related Pathology (4530); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 97 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, fracture of the poly liner and posterior medial tibial component, metallosis, instability, limited mobility, swelling, knee pain, and a grinding sensation.Initial surgery and revision surgery operative notes were provided.X-rays revealed metal on metal bilateral articulation with fracture posterior medial right tibial component as well as poly and fracture left posterior lateral tibial component and poly.Intraoperative findings indicated severe black tissue staining/metallosis throughout the knee and osteolysis of the femoral.The poly liner was to have severe wear.There was mild loosening of femoral component.The tibial component had fractured posterior medially where the metal femoral component had been articulating with the metal posterior edge of the tibial component.Multiple small fragments of the fractured poly were present and removed.The patella had severe wear present.The patient was revised to a competitor¿s devices.The patient appeared to have tolerated the procedure well and was subsequently transferred to the recovery room in good condition.No further issues or complications were reported.No images or x-rays were provided.No additional information is available.
Additional Manufacturer Narrative
D10: (b)(6) - 200-73-09 - cr tibial insert sz 3, 9mm, slope ++, (b)(6) - 200-04-34 - cemented finned tib.Tra sz 3f/4t, (b)(6) - 200-03-35 - one peg patella 35mm.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2022-01586, 1038671-2025-02163, 1038671-2025-02166.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, fracture, and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.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 POROUS FEMORAL, SZ 3, RIGHT
• 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 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22091412
• Report Number: 1038671-2025-02167
• Device Sequence Number: 12729370
• Product Code: JWH
• UDI-Device Identifier: 10885862063106
• UDI-Public: 10885862063106
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: 05/13/2017
• Device Catalogue Number: 232-03-03
• 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: 09/18/2023
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 05/30/2025
• Date Device Manufactured: 05/14/2012
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male