BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CERAMIC HEAD

    MDR report key: 7758569 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-05217
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    June 26, 2012
    Report Date
    August 30, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REMOVE CODE (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-104052 ¿ MALLORY/HEAD ACETABULAR SHELL ¿ 983800. EP-105933 ¿ E1 RINGLOC ACETABULAR LINER ¿ 667220. UNKNOWN ¿ UNKNOWN STEM - UNKNOWN. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES AND X-RAYS. REVIEW OF PRE-REVISION X-RAYS CONFIRM A PREVIOUS AVULSION FRACTURE FROM THE SUPERIOR ASPECT OF THE GREATER TROCHANTER. REVIEW OF THE OPERATIVE NOTES CONFIRMS PATIENT REPORT OF DISLOCATION IN CERTAIN POSITIONS WITH LOUD POP, BUT NO PAIN. THE CUP POSITION COULD BE MOVED MORE ANTEVERTED AND THERE ARE AREAS OF TROCHANTER THAT WERE BARE AND NOT HEALED, HOWEVER THE STEM WAS WELL FIXED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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). REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. CONCOMITANT MEDICAL PRODUCTS: ITEM # UNK, STEM, LOT # UNK; ITEM # UNK, SHELL, LOT # UNK; ITEM # UNK, LINER, LOT # UNK. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 05215; 0001825034 - 2018 - 05216.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 1 YEAR POST IMPLANTATION, PATIENT UNDERWENT A REVISION DUE TO MALPOSITION OF ACETABULAR CUP THAT LEAD TO MULTIPLE DISLOCATIONS AND SUBLUXATIONS. THE CUP, LINER, HEAD, AND TAPER ADAPTOR WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598904 BIOLOX DELTA CERAMIC HEAD PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 735600

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R