BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MOD HUM STEM 9MM

    MDR report key: 7480198 · Received May 2, 2018

    Report

    Report Number
    3002806535-2018-00776
    Event Type
    Injury
    Date Received
    May 2, 2018
    Date of Event
    March 29, 2018
    Report Date
    November 20, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWS
    PMA / PMN Number
    N/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.

    Additional Manufacturer Narrative · 0

    THE REASON FOR REVISION IS DUE TO DISEASE PROGRESSION RATHER THAN FAILURE OF THE IMPLANT. THEREFORE THIS INCIDENT IS NOT REPORTABLE.

    Description of Event or Problem · 0

    SHOULDER REVISION DUE TO CUFF FAILURE.

    Description of Event or Problem · 0

    CONVERSION OF A HEMI BIOMODULAR TO A REVERSED COMPREHENSIVE; HUMERAL BASEPLATE DID NOT FIT IN THE STEM, DIFFERENT TRUNION (CONUS). REVISION (CONVERSION TO REVERSED ARTHROPLASTY): BECAUSE OF MISMATCHING BETWEEN BIOMODULAR STEM AND COMPREHENSIVE HUMERAL BASEPLATE, STEM REMOVAL AND USE OF A CEMENTED TM STEM 8X200MM.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT - UNKNOWN EXT-BIO MODULAR-ANATOMIC/PRIMARY, 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: 3002806535-2018-00777.

    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. DEVICE HISTORY RECORD (DHR) FOR ITEM 113705 WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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
    322591 BIO-MOD HUM STEM 9MM KWS BIOMET UK LTD. N/A 1354256

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R