BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX DELTA MODULAR CERAMIC HEAD

    MDR report key: 6784006 · Received August 10, 2017

    Report

    Report Number
    3002806535-2017-00641
    Event Type
    Malfunction
    Date Received
    August 10, 2017
    Date of Event
    July 11, 2017
    Report Date
    April 9, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS RETURNED AND VISUALLY CHECKED WITH THE FOLLOWING OBSERVATION:- NO TOP OR BOTTOM FOAMS WERE NOT RETURNED WITH THE PACKAGING. THE BLISTER PACK WAS OPENED WHEN RECEIVED BACK AT BIOMET UK. PART OF THE POUCH SEAL WAS PARTLY OPEN. (SEAL OPENED FURTHER TO CHECK EXTENT OF THE OPEN SEAL) NO DAMAGE TO BLISTER AND CARDBOARD CARTON. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN ¿ EVENT OCCURRED IN (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(6) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WARSAW MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K051411. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER NOTICED THROUGH THE BLISTER THAT THE PACKAGING IN NOT UNDER VACUUM. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565120 BIOLOX DELTA MODULAR CERAMIC HEAD PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 2017020570

    Patients

    Seq Age Sex Outcome Treatment
    1