BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR 6MM HUM FRACT STEM PPS

    MDR report key: 9967236 · Received April 16, 2020

    Report

    Report Number
    0001825034-2020-01547
    Event Type
    Injury
    Date Received
    April 16, 2020
    Date of Event
    March 23, 2020
    Report Date
    August 14, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    UDI-DI
    00880304591530
    PMA / PMN Number
    K140652
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G3: JAPAN. REPORTED EVENT WAS CONSIDERED CONFIRMED FROM THE X-RAYS WHICH STATED THAT THE HARDWARE WAS DISASSOCIATED AND THAT THERE IS LIKELY DISLOCATION OF THE HUMERUS AND GLENOID WHICH IS RELATED TO A FRACTURED AND DISASSEMBLED COMPONENT OF THE HUMERUS HARDWARE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 113760, BIO-MOD HUM HEAD 40DIAX15MM, LOT # 401330. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE STEM REMAINS IMPLANTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01546. WILL BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INITIAL OPERATION WAS PERFORMED APPROXIMATELY A MONTH AGO. SUBSEQUENTLY, THE HEAD IMPLANT DISASSOCIATED FROM THE STEM MAKING THE JOINT DISLOCATED A WEEK LATER WITH NO PAIN. A REVISION WAS PERFORMED TWO (2) DAYS AFTERWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431532 COMPR 6MM HUM FRACT STEM PPS PROSTHESIS, SHOULDER HSD ZIMMER BIOMET, INC. N/A 339720 00880304591530

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R