BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA FEMORAL IMPACTOR PAD

    MDR report key: 6157735 · Received December 9, 2016

    Report

    Report Number
    0001822565-2016-04592
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 7, 2016
    Report Date
    October 6, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113369
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED SECTION OF THE PERSONA FEMORAL CR IMPACTOR PADS CONFIRMED THAT THE PARTS HAD FRACTURED. IT WAS ALSO NOTED THERE WERE SCRATCHES, NICKS AND GENERAL WEAR ON THE RETURNED IMPACTION SURFACES INDICATIVE OF REPEATED USE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING THE TRIALING PROCESS OF KNEE ARTHROPLASTY, THE IMPACTOR PAD FRACTURED IN TWO PIECES. IT WAS REPORTED THAT NO FRAGMENTS OF THE IMPACTOR PAD WERE LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809633 PERSONA FEMORAL IMPACTOR PAD KNEE INSTRUMENT JWH ZIMMER, INC. N/A 62544362

    Patients

    Seq Age Sex Outcome Treatment
    1