BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CC TIBIAL INSERT SZ 2, 9MM

    MDR report key: 16731040 · Received April 13, 2023

    Report

    Report Number
    1038671-2023-00667
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    August 17, 2022
    Report Date
    May 7, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862054166
    PMA / PMN Number
    K954208
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION RESULTS - THE REVISION REPORTED WAS LIKELY THE RESULT OF POLYETHYLENE WEAR AS STATED IN THE LEGAL DOCUMENTATION. HOWEVER, THE EXTENT AND ROOT CAUSE OF THE POLYETHYLENE WEAR CANNOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND IMAGES, RADIOGRAPHS, AND OPERATIVE NOTES WERE NOT PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THE FOLLOWING FIELDS HAVE BEEN UPDATED/CORRECTED: D7A, D8, F10 - SHOULD BE BLANK, THIS IS A MANUFACTURER'S REPORT, G4, H7, AND H9.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3/G4, H6. THE FOLLOWING SECTIONS WERE CORRECTED: D4, H6 . MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, F, G. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INSTABILITY 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.

    Description of Event or Problem · 0

    LEGAL CASE - (B)(6). INDEX: (B)(6) 2012. REVISION: (B)(6) 2022. 12-APR-2023 SW ADDITIONAL INFORMATION RECEIVED FROM LEGAL DOCUMENT ON 17-MAR-2023 (B)(6). RELATED CASE(B)(4). (B)(4) 208-22-09 CC TIBIAL INSERT. SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K954208. IN A REPORT VIA LEGAL DEPARTMENT, ON (B)(6) 2012, THE PATIENT UNDERWENT LEFT TOTAL KNEE REPLACEMENT SURGERY WHERE SHE WAS IMPLANTED WITH A RECALLED OPTETRAK CC POLYETHYLENE TIBIAL INSERT (SERIAL #: (B)(4)). ON (B)(6) 2015, THE PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT SURGERY WHERE SHE WAS IMPLANTED WITH AN OPTETRAK ARTICULAR NON-MODULAR POLYETHYLENE TIBIAL INSERT. ON (B)(6) 2022, APPROXIMATELY 9 YEARS AND 9 MONTHS AFTER INITIAL SURGERY, THE PATIENT UNDERWENT LEFT TOTAL KNEE REVISION SURGERY DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE OPTETRAK CC POLYETHYLENE TIBIAL INSERT. THE PATIENT EXPERIENCES PAIN IN HER RIGHT KNEE AND WILL LIKELY REQUIRE A REVISION SURGERY TO REMOVE THE REMAINING OPTETRAK DEVICE. 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 ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222277 CC TIBIAL INSERT SZ 2, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. CC TIBIAL INSERT SZ 2, 9MM UNK 10885862054166

    Patients

    Seq Age Sex Outcome Treatment
    1