BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ILOK STEM TIB TRAY 67MM

    MDR report key: 6305768 · Received February 6, 2017

    Report

    Report Number
    0001825034-2017-00478
    Event Type
    Injury
    Date Received
    February 6, 2017
    Date of Event
    January 9, 2017
    Report Date
    April 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBV
    PMA / PMN Number
    PK010212
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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

    CONCOMITANT MEDICAL PRODUCTS: ITEM NAME: E1 VNGD AS TIB BRG 10X63, ITEM NUMBER: EP-189020, LOT NUMBER: 225960. ITEM NAME: BIOMET TIB BLOCK 6MM 67, ITEM NUMBER: 141742, LOT NUMBER: 930680. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2017-00480/00481).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED FOR TIBIAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88187 BIOMET ILOK STEM TIB TRAY 67MM PROTHESIS, KNEE MBV BIOMET ORTHOPEDICS N/A 944320

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R