BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCEED ABT STD SHELL PC DIA50M M

    MDR report key: 5800002 · Received July 16, 2016

    Report

    Report Number
    3002806535-2016-00557
    Event Type
    Injury
    Date Received
    July 16, 2016
    Date of Event
    June 7, 2016
    Report Date
    October 8, 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
    FI
    Reporter Occupation
    PHYSICIAN

    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. PMA 510(K) - 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.

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF MANUFACTURING HISTORY REVEALED NO EVIDENCE OF PRODUCT NONCONFORMANCE AND DEVICE LIKELY LEFT THE MANUFACTURER CONFORMING TO PRINT. EXAMINATION OF THE ACETABULAR CUP REVEALED THE LINER WAS STILL ASSEMBLED WHEN RECEIVED. THE RIM OF THE CUP WAS NOTED TO HAVE SOME FLATTENING, WHICH IS LIKELY THE RESULT OF CONTACT WITH THE FEMORAL COMPONENT OR COULD HAVE BEEN DAMAGE DONE DURING EXTRACTION. THE MOST LIKELY ROOT CAUSE OF THE EVENT IS MALPOSITIONED ACETABULAR CUP; HOWEVER, A CONCLUSIVE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    PATIENT WAS REVISED ON THE RIGHT SIDE APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO AUDIBLE NOISE, PAIN, UNKNOWN MECHANICAL COMPLICATIONS, AND SNAPPING. DURING THE PROCEDURE, THE SURGEON NOTED THE ACETABULAR CUP WAS INCORRECTLY POSITIONED INITIALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454340 EXCEED ABT STD SHELL PC DIA50M M PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 2568175

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R