BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXT-BIO MODULAR-ANATOMIC/PRIMARY

    MDR report key: 7480205 · Received May 2, 2018

    Report

    Report Number
    3002806535-2018-00777
    Event Type
    Injury
    Date Received
    May 2, 2018
    Date of Event
    March 29, 2018
    Report Date
    October 4, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    SHOULDER REVISION DUE TO CUFF FAILURE.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT - BIO-MOD HUM STEM 9MM,ITEM 113705, LOT 1354256, THERAPY DATE - (B)(6) 2018. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2018-00776.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM CUSTOMER. 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. 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 THE PATIENT UNDERWENT AN INITIAL SHOULDER PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS CONVERTED FROM A HEMI-BIOMODULAR TO A REVERSED COMPREHENSIVE SHOULDER DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322599 UNKNOWN EXT-BIO MODULAR-ANATOMIC/PRIMARY KWS BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R