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

Catalog Number	230-03-03
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Scar Tissue (2060); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Joint Laxity (4526); Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	08/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
"d10: 200-63-13 - cr tibial insert sz 3, 13mm, slope +; 204-04-34 - trapezoid tibial tray sz 3f/4t.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-00533.The revision reported may have been the result of polyethylene liner wear with resulting osteolysis and aseptic loosening of the femoral and tibial components as stated in the legal documentation.The loosening may have been the result of an insufficient bond between the implants and the bones.The extent of the reported polyethylene wear cannot be determined as the devices were not available for evaluation and images of the explanted devices, pre-revision radiographs, and operative notes were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.".
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement.Approximately 55 months after the initial procedure the patient had a right knee revision due to the polyethylene liner wear with resulting osteolysis and aseptic loosening of the femoral and tibial components.The loosening may have been the result of an insufficient bond between the implants and the bones.The extent of the reported polyethylene wear cannot be determined as the devices were not available for evaluation and images of the explanted devices, pre-revision radiographs, and operative notes were not provided.It was additionally noted that despite undergoing revision surgery the patient experiences daily knee pain and discomfort which limits the patient's activities of daily living and recreation and impacts the patient's quality of life.There is no other patient demographic or medical history available.No additional information is available.

• Brand Name: OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 3,
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21273365
• Report Number: 1038671-2025-00559
• Device Sequence Number: 12801105
• Product Code: JWH
• UDI-Device Identifier: 10885862061751
• UDI-Public: 10885862061751
• Combination Product (Y/N): N
• 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: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2025

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: 08/24/2016
• Device Catalogue Number: 230-03-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 01/30/2025
• Date Device Manufactured: 08/29/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male