BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLORY-HEAD ACETABULAL SHELL

    MDR report key: 6522336 · Received April 26, 2017

    Report

    Report Number
    3002806535-2017-00249
    Event Type
    Malfunction
    Date Received
    April 26, 2017
    Date of Event
    March 29, 2017
    Report Date
    December 14, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN ¿ EVENT OCCURRED IN (B)(6). ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K042037. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT, THE SHELL WOULD NOT SEAT. AFTER MULTIPLE ATTEMPTS, IT WAS FOUND THE LOCKING RING MAY BE STOPPING THE SEATING OF THE SHELL. THE LOCKING RING WAS REMOVED, A NEW LOCKING RING WAS PLACED., AND THE SHELL WAS ABLE TO SEAT. THERE WAS A 20 MINUTE DELAY IN PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303199 MALLORY-HEAD ACETABULAL SHELL PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 2936518

    Patients

    Seq Age Sex Outcome Treatment
    1 RINGLOC LINER PN:EP-105923 LN:100780