BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC SHELL IMPACTOR HANDLE

    MDR report key: 3132079 · Received May 29, 2013

    Report

    Report Number
    3002806535-2013-00090
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. DEVICE EVALUATION IN PROCESS. UPON COMPLETION OF EVALUATION, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. THIS IS 2 OF 2 MDR REPORTS SUBMITTED FOR THE SAME EVENT. (SEE 3002806535-2013-00089/90).

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE MALLORY SHELL AND THE IMPACTOR HANDLE IT WAS CLEAR TO SEE THAT THE SHELL IMPACTOR HAD BEEN SCREWED INTO THE MALLORY SHELL INCORRECTLY. A REVIEW OF THE MANUFACTURING HISTORY RECORDS FOR BOTH ITEMS CONCERNED CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINT DATABASE HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THESE ITEMS/LOT COMBINATION. IT WAS CONCLUDED THE ITEMS HAVE BEEN CROSS THREADED DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PRIMARY HIP PROCEDURE ON (B)(6) 2013, THE SURGEON TRIED TO REMOVE THE IMPACTOR HANDLE FROM THE IMPLANTED ACETABULAR SHELL, BUT IT WAS LOCKED ON THE SHELL AND WOULD NOT COME OFF. SURGEON HAD TO REMOVE THE SHELL AND REPLACE IT WITH A NEW SHELL USING A DIFFERENT IMPACTOR HANDLE. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234641 RINGLOC SHELL IMPACTOR HANDLE MANUAL SURGICAL INSTRUMENT LXH BIOMET UK LTD. N/A ZB100201

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R