BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS CNTRL 6.5X20MM ST/RST

    MDR report key: 9376292 · Received November 26, 2019

    Report

    Report Number
    0001825034-2019-05149
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    December 13, 2018
    Report Date
    November 13, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    UDI-DI
    00880304677067
    PMA / PMN Number
    K113121
    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 · 1

    PROCODE: PHX. (B)(4). MULTIPLE MDR'S WERE FILED IN ASSOCIATION WITH THIS REPORTING: 0001825034 -2019 -05143, 0001825034 -2019 -05144, 0001825034 -2019 -05145, 0001825034 -2019 -05146, 0001825034 -2019 -05147. CONCOMITANT MEDICAL PRODUCTS: TAPER ADAPTOR 115310 LOT:222460, NON-LOCKING SCREWS 180558 LOT:860890, NON-LOCKING SCREW 180557 LOT 217280, FIXED SCREW 180551 LOT: 455490, FIXED SCREW 180550 LOT 494250, MINI BASEPLATE 010000589 LOT:357320, MINISTEM 113632 LOT:300720 , HUMERAL BEARING XL115363 LOT 503500, HUMERAL TRAY 9707938-00 LOT 17013429, GLENOSPHERE 115310 222460. REPORT SOURCE: EVENT OCCURED IN THE (B)(6). NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED TO ADDRESS GLENOID IMPLANT RELATED BONE LOSS. SUBSEQUENT XRAYS SHOW GLENOSPHERE BASEPLATE HAS PULLED AWAY FROM BONE. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170972 COMP RVS CNTRL 6.5X20MM ST/RST SCREW, FIXATION, BONE HWC ZIMMER BIOMET, INC. N/A 572030 00880304677067

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R