BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 46X21X50 HUM HEAD

    MDR report key: 10421612 · Received August 18, 2020

    Report

    Report Number
    0001825034-2020-03218
    Event Type
    Injury
    Date Received
    August 18, 2020
    Date of Event
    August 29, 2017
    Report Date
    January 13, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    K060716
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE REMAINS AS CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: COMPR SRS PROX BDY - LG 42MM, CAT#: 211218, LOT#: 778200. COMPR SRS IC SEG - 60MM, CAT#: 211225, LOT#: 938540. COMPR SRS MOD RGX AUG ¿ LG, CAT#: 211229, LOT#: 154430. COMPR SRS MOD STEM - 9X100MM, CAT#: 211259, LOT#: 131780. REPORT SOURCE: (B)(6). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. DEVICE HISTORY RECORD (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 HAS BEEN REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT SHOULDER HEMIARTHROPLASTY PERFORMED. AT THE ONE YEAR FOLLOW UP VISIT, THE PATIENT REPORTED SEVERE PAIN, INCREASED LIMITATION TO ADLS, AND VERY LOW SATISFACTION LEVEL. UPON XRAY REVIEW, IT WAS NOTED THAT THE PROSTHESIS HAD MIGRATED DUE TO ROTATOR CUFF INSUFFICIENCY. NO INTERVENTION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886528 VERSA-DIAL 46X21X50 HUM HEAD SHOULDER, PROSTHESIS HSD ZIMMER BIOMET, INC. 120890

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R