BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP SHELL COCR HA/PC Ø54/48MM

    MDR report key: 5709653 · Received June 9, 2016

    Report

    Report Number
    3002806535-2016-00335
    Event Type
    Injury
    Date Received
    June 9, 2016
    Date of Event
    December 29, 2011
    Report Date
    May 10, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K042037. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 27 STATES, "WEAR AND CORROSION OF THE METAL COMPONENTS CAN CAUSE AN ¿ADVERSE LOCAL TISSUE REACTION (ALTR)¿ OR AN ¿ADVERSE REACTION TO METAL DEBRIS (ARMD)¿, WHICH CAN DAMAGE THE SURROUNDING BONE AND SOFT TISSUES." THIS REPORT IS NUMBER 5 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2013-00165 & 1825034-2013-03659 & 3002806535-2015-04043 & 3002806535-2016-00334 / 00335). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS THEREIN ARE UNVERIFIED. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THE PATIENT UNDERWENT A LEFT TOTAL HIP REVISION PROCEDURE APPROXIMATELY THIRTY-TWO MONTHS POST-IMPLANTATION DUE TO ALLEGATIONS OF CLICKING SENSATION, STIFFNESS, DISCOMFORT AND ELEVATED METAL ION LEVELS THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365763 RECAP SHELL COCR HA/PC Ø54/48MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1643307

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R