BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 7414663 · Received April 10, 2018

    Report

    Report Number
    0001825034-2018-02476
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    September 23, 2016
    Report Date
    September 14, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT MEDICAL PRODUCTS: EP-115393, E1 44-36 STD HMRL BRNG, 769470. THE 115310, COMP RVRS SHLDR GLNSP STD 36MM, 607900. THE 115370, COMP RVS TRAY CO 44MM, 417300. THE 113633, COMP PRIMARY STEM 13MM MINI, 932850. THE 180552, COMP LK SCR 3.5HEX 4.75X25 ST, 047960. THE 115397, COMP RVS CNTRL 6.5X35MM ST/RST, 261750. THE 180550, COMP LK SCR 3.5HEX 4.75X15 ST, 492460. THE 180550, COMP LK SCR 3.5HEX 4.75X15 ST, 135290. THE 180553, COMP LK SCR 3.5HEX 4.75X30 ST, 870160. 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: 0001825034-2018-02475, 0001825034-2018-02478.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI # (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT LEFT HIP REVISION DUE PAIN, DISASSOCIATION OF GLENOSPHERE AND BASEPLATE, AND STEM LOOSENING. ALL COMPONENTS WERE REVISED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254683 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 683150

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R