BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP SHELL COCR HA/PC DIA52/46MM

    MDR report key: 5869985 · Received August 11, 2016

    Report

    Report Number
    3002806535-2016-00680
    Event Type
    Injury
    Date Received
    August 11, 2016
    Date of Event
    August 7, 2012
    Report Date
    July 14, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    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 DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K042037. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THESE TYPES OF EVENTS CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ NUMBER 28 STATES, ¿PAIN, SWELLING, OR THE ONSET OF A LIMP MAY OCCUR, REQUIRING FURTHER EVALUATION FROM AN ORTHOPAEDIC SURGEON.¿ THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2015-00251). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT REVISION PROCEDURE APPROXIMATELY THREE YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S MEDICAL RECORDS REVEALS PATIENT UNDERWENT A RIGHT REVISION PROCEDURE APPROXIMATELY THREE YEARS POST-IMPLANTATION DUE TO PAIN, DISCOMFORT , POSSIBLE LOOSENING OF THE ACETABULAR COMPONENT, AND FLUID WITHIN THE JOINT. DURING THE PROCEDURE, FLUID IS NOTED WITHIN THE JOINT. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED WITH COMPETITOR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522304 RECAP SHELL COCR HA/PC DIA52/46MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1720156

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R