BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP SHELL COCR PC 58/52MM

    MDR report key: 3781494 · Received April 30, 2014

    Report

    Report Number
    3002806535-2014-00119
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    April 4, 2014
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. AS PRODICT IS STILL IMPLANT, NO PRODUCT HAS BEEN RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. DATE OF EVENT - UNKNOWN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S NOTICE AND THE ALLEGATIONS THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT A HIP RESURFACING PROCEDURE ON (B)(6), 2007 AND IS SUBSEQUENTLY REPORTING PAIN AND LIMITED MOBILITY FOUR MONTHS FOLLOWING THE PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S NOTICE AND THE ALLEGATIONS THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260949 RECAP SHELL COCR PC 58/52MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1186118

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R