MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 2, LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	244-02-02
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1038671-2023-00900 report number." d10: (b)(6) - optetrak hi-flex tibial insert, sz 2, 11mm, (b)(6) - three peg patella 32mm, (b)(6) - cemented finned tib.Tra sz 2f/2t.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-00900.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, tibial loosening, 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.".
Event or Problem Description
As reported via legal documentation, this patient underwent a left total knee arthroplasty.After the left total knee replacement surgery, the patient began to suffer from symptoms including but not limited to prosthetic wear, instability and loosening, pain and lack of mobility.As a result of these symptoms, patient underwent left knee revision surgery approximately 2 years 4 months after their initial replacement.The revision reported may have been the result of an insufficient bond between the implants and the bones, which left to aseptic (non-infected) loosening and instability.However, this cannot be confirmed as the explanted devices were not returned for evaluation, and radiographs/photographs were not provided.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No further issues or complications were reported.No additional information is available.

• Brand Name: OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 2, LEFT
• 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: 21255221
• Report Number: 1038671-2025-00498
• Device Sequence Number: 12776539
• Product Code: JWH
• UDI-Device Identifier: 10885862063779
• UDI-Public: 10885862063779
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• 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
• Report Date (Section B): 01/28/2025

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: 01/29/2019
• Device Catalogue Number: 244-02-02
• 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: 01/27/2025
• Initial Report FDA Received Date: 01/28/2025
• Date Device Manufactured: 01/31/2014
• 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: 73 YR
• Patient Sex: Female