BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO MODULAR HUMERAL STEM

    MDR report key: 7279706 · Received February 19, 2018

    Report

    Report Number
    0001825034-2018-00671
    Event Type
    Injury
    Date Received
    February 19, 2018
    Report Date
    February 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    PK030710
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN WHICH STEM IS IMPLANTED IN THE RIGHT SHOULDER. LOT# 214910 OR 051420, STERILE DATE: MAR 31, 2011 OR OCT 31, 2012. IMP DATE: (B)(6) 2002 OR (B)(6) 2002. MFG DATE: MAR 9, 2001 OR OCT 25, 2002. MEDICAL PRODUCT: BIO-MOD GLENOID, CATALOG#: 113870, LOT#: 690580 OR 001000; BIO-MOD HUM HEAD, CATALOG#: 113760, LOT#: 796750 OR 961790; BIO-MOD CENTERING SLEEVE, CATALOG#: 113789, LOT#: 924610. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. 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 HAD AN INITIAL RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAS BEEN INDICATED FOR A REVISION DUE TO LOOSENING OF IMPLANT. CONSTRAINED, CUSTOM SHOULDER COMPONENTS HAVE BEEN REQUESTED FOR REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123130 BIO MODULAR HUMERAL STEM POSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R