BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE HUMERAL BEARING ASSEMBLY

    MDR report key: 6490807 · Received April 13, 2017

    Report

    Report Number
    0001825034-2017-02535
    Event Type
    Injury
    Date Received
    April 13, 2017
    Report Date
    September 7, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PCUSTOM
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT: TITANIUM SCREW LOW PROFILE, CATALOG#: 113848, LOT#: 380000. RS TI BONE SCREW, CATALOG#: CP560865, LOT#: 699380, QTY = 2. TI LOW PROFILE SCREW, CATALOG#: 103536, LOT#: 229360. CUSTOM REVERSE SHOULDER GLENOSPHERE BASE, CATALOG#: CP560830, LOT#: 828860. CUSTOM BIO-MODULAR GLENOSPHERE, CATALOG#: CP561204, LOT#: 540950. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY COULD NOT BE ADEQUATELY PERFORMED AS THE REASON FOR INDICATED REVISION 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED AT THIS TIME. 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 A PATIENT HAS BEEN INDICATED FOR A REVISION OF BIO-MODULAR HUMERAL COMPONENTS DUE TO UNKNOWN REASONS. NO REVISION HAS BEEN REPORTED TO DATE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAS BEEN INDICATED FOR A REVISION OF A BIO-MODULAR SHOULDER DUE TO UNKNOWN REASONS. 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
    273204 REVERSE HUMERAL BEARING ASSEMBLY PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 076450

    Patients

    Seq Age Sex Outcome Treatment
    1 Other