BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI REVERSE GLENOID CONST

    MDR report key: 8564608 · Received April 30, 2019

    Report

    Report Number
    0001825034-2019-01948
    Event Type
    Injury
    Date Received
    April 30, 2019
    Report Date
    May 16, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    CUSTOM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: CP0001582, CONSTRAINED GLENOID 22MM LINER, LOT 734120, CP0001581, CONSTRAINED GLENOID LOCK RING, LOT UNK, 211230, COMPR SRS MOD STEM - 6X75MM, LOT 541500, 211216, COMPR SRS PROX BDY - SM 58MM, LOT 688930, CP0001584, COMPR SRS TMR BODY 61MM W THDS, LOT UNK, CP0001583, CONST 22MM HMRL HEAD W SCREW, LOT UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WILL BE UNDERGOING A REVISION OF A CANNULATED CONSTRAINED CUP TO A REVERSE BASEPLATE APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO DISASSOCIATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360078 MINI REVERSE GLENOID CONST PROSTHESIS, SHOULDER HSD ZIMMER BIOMET, INC. N/A 884050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R