BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEED ABT ACETABULAR COMPONENT 46MM

    MDR report key: 6740215 · Received July 25, 2017

    Report

    Report Number
    3002806535-2017-00613
    Event Type
    Malfunction
    Date Received
    July 25, 2017
    Date of Event
    June 26, 2017
    Report Date
    April 16, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN ¿ EVENT OCCURRED IN (B)(6). 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 (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K042037. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST WAS MADE BY (B)(4) FOR (B)(4) TO RETAIN THE PRODUCT AS THE REGENEREX SHELL WAS NOT MANUFACTURED IN THE (B)(6). THE INVESTIGATION WAS ABLE TO IDENTIFY THE REGENEREX SHELL THAT WAS FOUND IN THE EXCEED ABT RINGLOC-X PACKAGING FROM THE INFORMATION IN THE PHOTOGRAPHS SUPPLIED BY (B)(4). A SEARCH WAS CARRIED OUT IN SAP TO IDENTIFY THE MOVEMENT OF EACH OF THE PRODUCTS WITH THE RESULTS AS FOLLOWS: ITEM (B)(4), LOT 440650 REGENEREX SHELL, MANUFACTURED IN (B)(4) - 24 APR 2014. ITEM (B)(4), LOT 3411676 EXCEED ABT RINGLOC-X SHELL, MANUFACTURED IN BRIDGEND - 23 SEP 2014. ONE REGENEREX SHELL (PT-1160050, 440650) WAS SHIPPED TO GSCC ON (B)(6) 2014 AND THEN SHIPPED TO (B)(4) ON (B)(6) 2014. SIX EXCEED ABT RINGLOC-X SHELLS WERE SHIPPED TO GSCC ON (B)(6) 2014 AND THEN ONE WAS SHIPPED TO (B)(4) ON (B)(6) 2014. A REVIEW OF THE COMPLAINTS DATA BASE HAS CONFIRMED THAT THERE ARE NO FURTHER EVENTS REPORTED FOR THE LOT NUMBERS RECORDED IN THIS COMPLAINT. THE INVESTIGATION HAS CONCLUDED THAT THE ONLY TIME THESE TWO PRODUCT WERE IN THE SAME LOCATION AT THE SAME TIME IS AT (B)(4).

    Additional Manufacturer Narrative · 1

    (UDI) # - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE BOX FOR AN ACETABULAR SHELL WAS OPENED. INSIDE THE BOX WAS THE INCORRECT SIZE AND BRAND OF PRODUCT. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522694 EXCEED ABT ACETABULAR COMPONENT 46MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 3411676

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN 50MM REGENEREX REVISION CUP