BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP STD 36MM

    MDR report key: 7414668 · Received April 10, 2018

    Report

    Report Number
    0001825034-2018-02475
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    September 23, 2016
    Report Date
    August 16, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    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 · 0

    (B)(4). UPON RECEIPT OF INFORMATION RECEIVED AND REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE, AS THIS DEVICE DID NOT CAUSE NOR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT MEDICAL PRODUCTS: EP-115393, E1 44-36 STD HMRL BRNG, 769470. THE 115370, COMP RVS TRAY CO 44 MM, 417300. THE 010000589, COMP RVRS 25 MM BSPLT HA+ADPTR, 683150. THE 113633, COMP PRIMARY STEM 13 MM MINI, 932850. THE 180552, COMP LK SCR 3.5HEX 4.75X25 ST, 047960. THE 115397, COMP RVS CNTRL 6.5 X 35 MM 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: 0001825034-2018-02476, 0001825034-2018-02478.

    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
    255222 COMP RVRS SHLDR GLNSP STD 36MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 607900

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R