BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TRAY

    MDR report key: 7288602 · Received February 22, 2018

    Report

    Report Number
    0001825034-2018-01284
    Event Type
    Injury
    Date Received
    February 22, 2018
    Report Date
    April 5, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 115397, COMP RVS CNTRL 6.5X35MM ST/RST, 938510, 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, 951230, 180555, COMP LK SCR 3.5HEX 4.75X40 ST, 350220, 180553, COMP LK SCR 3.5HEX 4.75X30 ST, 770260, 180550, COMP LK SCR 3.5HEX 4.75X15 ST, 541550, 180552, COMP LK SCR 3.5HEX 4.75X25 ST, 593070, 180553, COMP LK SCR 3.5HEX 4.75X30 ST, 800380, 115310, COMP RVRS SHLDR GLNSP STD 36MM, 670960, UNKNOWN, UNKNOWN BEARING, UNKNOWN, UNKNOWN, UNKNOWN STEM, UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 00973, 0001825034 - 2018 - 00974, 0001825034 - 2018 - 01157, 0001825034 - 2018 - 01158, 0001825034 - 2018 - 01159, 0001825034 - 2018 - 01160, 0001825034 - 2018 - 01161, 0001825034 - 2018 - 01162, 0001825034 - 2018 - 01283, 0001825034 - 2018 - 01282.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 WAS REPORTED A PATIENT IS EXPERIENCING LIMITED RANGE OF MOTION OF THEIR SHOULDER APPROXIMATELY ONE YEAR POST-IMPLANTATION. NO INTERVENTION OR TREATMENT HAS BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT HAS NOT BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134376 UNKNOWN TRAY PROSTHESIS, SHOULDER HSD ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O