MAUDE Adverse Event Report: Exactech, Inc. OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 2; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal

Catalog Number	234-03-02
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Report #2 of 3 for this event.It was reported this patient had an initial right total knee arthroplasty.Subsequently, fourteen (14) years, ten (10) months later, the patient began experiencing worsening symptoms, pain, instability, effusion, and antalgic gate.As a result, the patient required a right total knee revision procedure.An operative report was provided.The patient was revised due to periprosthetic osteolysis of the right knee joint.Intraoperatively, there was significant effusion and synovitis.The tibial insert showed delamination with no evidence of loosening.The femoral component was debonded and removed without significant bone loss.The patella was worn and loose.The patient was revised to another manufacturer's construct.The patient tolerated the procedure well and was transferred to the recovery room in stable condition.Additionally, it was reported via legal documentation the patient continues to experience pain and discomfort on a daily basis in both knees which limits daily activities and quality of life.No further information is available.

• Brand Name: OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 2
• 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: julia goldberg ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 50207815
• Report Number: 1038671-2026-01002
• Device Sequence Number: 10274626
• Product Code: JWH
• UDI-Device Identifier: 10885862063250
• UDI-Public: 10885862063250
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2012
• Device Catalogue Number: 234-03-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 08/11/2026
• 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 Sex: Female