BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET UNKNOWN STEM

    MDR report key: 7756963 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-04990
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    October 6, 2011
    Report Date
    July 25, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: EP-105994 - EPOLY 28MM RNGLC LNR ¿ 378780; 12-115122 ¿ BIOLOX-DELTA MODULAR CERAMIC HEAD ¿ 970930; UNKNOWN - UNKNOWN SHELL - UNKNOWN. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. REVIEW OF X-RAYS SHOWS MINIMAL LUCENCY AT THE TIP OF THE FEMORAL STEM. A SMALL AMOUNT OF HETEROTOPIC OSSIFICATION HAS DEVELOPED SUPERIOR TO THE GREATER TROCHANTER. DEVICE HISTORY RECORD (DHR) 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 04993.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY 15 MONTHS POST IMPLANTATION DUE TO LOOSENING OF THE ACETABULAR COMPONENT. THE CUP WAS REMOVED AND REPLACED. THE LINER AND HEAD WERE ALSO REPLACED APPROXIMATELY 9 MONTHS POST FIRST REVISION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599640 BIOMET UNKNOWN STEM HIP PROSTHESIS JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R