BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR 12MM IM HMRL

    MDR report key: 8471385 · Received April 1, 2019

    Report

    Report Number
    0001825034-2019-01387
    Event Type
    Injury
    Date Received
    April 1, 2019
    Report Date
    May 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    CUSTOM
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT CANNOT BE CONFIRMED AS NO MEDICAL RECORDS OR X-RAYS WERE PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES. ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT CODE- MBF. UDI: (B)(4). 510K A SIMILAR DEVICE IS CLEARED UNDER K060692. CONCOMITANT MEDICAL PRODUCTS: CP562391 DISC LT DSTL HMRL BDY SET 050970; UNKNOWN DISCOVERY ULNA; UNKNOWN ARTICULATION KIT. THE COMPLAINT IS UNDER INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2019 -01390.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HUMERAL/DISTAL HUMERAL REPLACEMENT. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION DUE TO DISASSOCIATION OF THE LINKAGE BETWEEN THE DISTAL HUMERAL AND TOTAL HUMERAL COMPONENTS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262125 COMPR 12MM IM HMRL PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 047750

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention