BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC 6.5 X 75MM IM STEM

    MDR report key: 6934969 · Received October 10, 2017

    Report

    Report Number
    0001825034-2017-08294
    Event Type
    Injury
    Date Received
    October 10, 2017
    Date of Event
    January 5, 2011
    Report Date
    January 23, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    PK020045
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: MOSAIC MOD PROX HMRL SEG 80 MM PN111003 LN491540, DISC-MOSAIC LT +10 MOD DSTL PN114892 LN499000, DISC CONDYLE KIT W/ HEXALOBULA PN114700 LN491340, DISC ULNA 3 X 75 MM LT W/BRNG C PN114812 LN791070. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT UNDERWENT RIGHT ELBOW ARTHROPLASTY. SUBSEQUENTLY IN ONE YEAR WAS REVISED DUE TO UNKNOWN REASONS. ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715305 MOSAIC 6.5 X 75MM IM STEM PROSTHESIS, ELBOW KWT ZIMMER BIOMET, INC. N/A 825940

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| R