MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 3, LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	244-02-03
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); Scar Tissue (2060); Synovitis (2094); Joint Laxity (4526)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 146 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, loosening, instability, joint laxity, pain, scar tissue, synovitis, and failure of implant.Revision surgery operative notes were provided.Patient left the operating room in stable condition.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
1038671-2023-00721, 1038671-2024-05108 multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-00721, 1038671-2024-05108.D10: concomitants: (b)(6), 200-02-32 - three peg patella 32mm, (b)(6), 200-04-33 - cemented finned tib.Tra sz 3f/3t, (b)(6), 203-97-14 - zimmer series 11-3729-01 3 versipower pl 90x25x1, (b)(6), 244-02-03 - optetrak asy hi-flex ps cem fem, sz 3, left, (b)(6), 244-23-09 - optetrak hi-flex tibial insert sz 3 9mm.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, femoral loosening, and tibial loosening or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.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 HI-FLEX PS CEM FEM, SZ 3, 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: 21048300
• Report Number: 1038671-2024-05109
• Device Sequence Number: 3277361
• Product Code: JWH
• UDI-Device Identifier: 10885862063786
• UDI-Public: 10885862063786
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2023
• 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): 12/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 244-02-03
• 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: 02/19/2024
• Initial Report FDA Received Date: 12/31/2024
• Date Device Manufactured: 11/02/2010
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 64 YR
• Patient Sex: Female