BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY/HEAD RADIAL SHELL POROUS COAT 58MM

    MDR report key: 6541482 · Received May 3, 2017

    Report

    Report Number
    0001825034-2017-03054
    Event Type
    Injury
    Date Received
    May 3, 2017
    Date of Event
    March 8, 2011
    Report Date
    July 28, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK921181
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT - EPOLY RINGLOC LINER CATALOG#: EP-105895 LOT#: 958570, ECHO FEMORAL STEM CATALOG#: 192411 LOT#: 672690, FEMORAL HEAD CATALOG#: 11-363661 LOT#: 544610. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE ITEM AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE COULD NOT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY, THE ACETABULAR CUP "SPUN OUT" AT THE IMPLANT-BONE INTERFACE WHILE TESTING THE RANGE OF MOTION. THE ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324286 MALLORY/HEAD RADIAL SHELL POROUS COAT 58MM PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 248520

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention