BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSN A/S PROV L GH BOTTOM +0MM

    MDR report key: 7744534 · Received August 2, 2018

    Report

    Report Number
    0001822565-2018-04126
    Event Type
    Malfunction
    Date Received
    August 2, 2018
    Date of Event
    July 3, 2018
    Report Date
    February 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113369
    Removal / Correction Number
    Z-2296-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A PREVIOUS INVESTIGATION INTO THIS ISSUE DETERMINED THAT THE LIKELY ROOT CAUSE FOR THE TIBIAL ARTICULAR SURFACE PROVISIONAL (TASP) FRACTURES IS BENDING/TORSIONAL LOADING ON THE DEVICE. PERSONA TASP TOP COMPONENTS AND STANDARD (NON-CPS) TASP BOTTOM COMPONENTS HAVE BEEN MODIFIED TO PREVENT FRACTURE. THE FRACTURED COMPONENT IN THIS COMPLAINT WAS MANUFACTURED BEFORE THE DESIGN MODIFICATION WAS IMPLEMENTED. THE ROOT CAUSE IS CONSIDERED TO BE A PREVIOUSLY ADDRESSED DESIGN ISSUE. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATIONS COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT FRACTURED DURING STERILIZATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583992 PSN A/S PROV L GH BOTTOM +0MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI 62884214

    Patients

    Seq Age Sex Outcome Treatment
    1