BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS REVERSE HUMERAL TRAY

    MDR report key: 7889539 · Received September 19, 2018

    Report

    Report Number
    0001825034-2018-09011
    Event Type
    Injury
    Date Received
    September 19, 2018
    Date of Event
    April 30, 2013
    Report Date
    September 18, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    PCUSTOM
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CUSTOM COMPREHENSIVE SHOULDER, CAT. NO. CP561638, LOT NO. 276840; CRS GLENOSPHERE BASEPLATE, CAT. NO. 115330, LOT NO. 257320; CRS SCREW, CAT. NO. 115381, LOT NO. 233460; FIXED LOCKING SCREW, CAT. NO. 180501, LOT NO. 161030; FIXED LOCKING SCREW, CAT. NO. 180504, LOT NO. 516340; NONLOCKING SCREWS, CAT. NO. 180507, LOT NOS. 458080, 552560; STANDARD ADAPTER, CAT. NO. 118001, LOT NO. 372190; HUMERAL BEARING, CAT. NO. XL-115363, LOT NO. 418650; UNKNOWN HUMERAL STEM; CRS GLENOSPHERE; CAT. NO. 115310, LOT NO. 482970; HUMERAL BEARING, CAT. NO. XL-115363, LOT NO. 418650. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED HOWEVER, IT IS NOTED THAT THE PATIENT WAS DISLOCATED OVER A YEAR WHICH MAY HAVE CONTRIBUTED TO THE METALLOSIS. 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. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVERSE TOTAL SHOULDER ARTHROPLASTY REVISION APPROXIMATELY TWO (2) YEARS POST-IMPLANTATION DUE TO DISLOCATION, PAIN, AND INSTABILITY. IT WAS REPORTED THAT THE PATIENT HAD BEEN DISLOCATED FOR OVER A YEAR. DURING THE REVISION, A PSEUDOCAPSULE, METALLIC DEBRIS, AND METALLOSIS WERE NOTED IN THE JOINT. THE HUMERAL BEARING, ADAPTOR, LOCKING RING, AND GLENOSPHERE WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729591 ATLAS REVERSE HUMERAL TRAY PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. N/A 276840

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R