BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY HEAD LOANER KIT

    MDR report key: 3120019 · Received May 20, 2013

    Report

    Report Number
    3002806535-2013-00085
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT HAS BEEN RETURNED TO DATE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE - UNKNOWN.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION REVEALED THAT THE LOANER KIT ORDERED BY THE SURGEON (UHCUK MALLORY HEAD RINGLOC HAP ACET. CUP) CONTAINS CUPS ONLY. SURGEON MUST ORDER LOANER KIT ULJUK TO RECEIVE THE LINERS AND HEADS. LOANER TEAM HAS AMMENDED THE UHCUK LOANER SET LIST TO STATE THAT KIT ULJUK MUST ALSO BE BOOKED TO RECEIVE THE LINERS AND HEADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION HIP SURGERY ON (B)(6), 2013, THE SURGEON WENT TO IMPLANT THE NEW LINER, BUT NONE WAS AVAILABLE IN THE LOANER KIT. SURGEON HAD TO CLOSE UP THE PATIENT AND RE-OPERATE ON (B)(6), 2013 AFTER LINERS HAD BEEN SENT. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221391 MALLORY HEAD LOANER KIT PROSTHESIS, HIP JDI BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R