BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS 50MM DST HUM BDY RT

    MDR report key: 8657882 · Received May 31, 2019

    Report

    Report Number
    0001825034-2019-02101
    Event Type
    Injury
    Date Received
    May 31, 2019
    Date of Event
    January 9, 2019
    Report Date
    May 31, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    K173411
    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). MULTIPLE MDR'S WERE REPORTED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED EVENTS: 0001825034-2019-00241-1. PRIMARY DI NUMBER: (B)(4). NO DEVICE WAS RETURNED FOR EVALUATION. REVIEW OF PROVIDED PATIENT XRAYS CONFIRM DISASSOCIATION AND DISLOCATION. REVIEW OF DEVICE HISTORY RECORDS IDENTIFIED NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ROOT CAUSE IS UNKNOWN. 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 THE PATIENT WAS REVISED FOR A THIRD TIME TO ADDRESS ONGOING DISTAL BODY DISASSOCIATION FROM THE SRS IM STEM. THE IM STEM WAS REMOVED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453049 COMPR SRS 50MM DST HUM BDY RT PROSTHESIS, EXTREMITY MBF ZIMMER BIOMET, INC. N/A 970660

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R 211259 SRS MOD STEM - LOT 639440