BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X15 ST

    MDR report key: 8713291 · Received June 19, 2019

    Report

    Report Number
    0001825034-2019-02459
    Event Type
    Injury
    Date Received
    June 19, 2019
    Report Date
    July 15, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K132239
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI : (B)(4). NO DEVICE WAS RETURNED FOR EVALUATION. REVIEW OF DEVICE HISTORY RECORDS IDENTIFIED NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. HOWEVER, IT WAS REPORTED THE PATIENT FELL CAUSING THE PATIENT GLENOID TO FRACTURE AND THE CONSTRUCT TO PULL AWAY. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO HUMAN FACTOR ISSUE. 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 · 0

    NO FURTHER INFORMATION AVAILABLE AT THIS TIME OF THIS REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT(S): 0001825034-2019-02456, 0001825034-2019-02457, 0001825034-2019-02458, 0001825034-2019-02460, CONCOMITANT MEDICAL PRODUCTS: 115330, LOT 410400, COMP RVRS SHDR GLEN 28MM BSPLT +HA, UDI #: (B)(4). 180550, LOT 540630, COMP LK SCR 3.5HEX 4.75X15 ST, UDI #: (B)(4). 115396, LOT 479990, COMP RVS CNTRL 6.5X30MM ST/RST, UDI #: (B)(4). 180550, LOT 432280, COMP LK SCR 3.5HEX 4.75X15 ST, UDI #: (B)(4). 180550, LOT 540690, COMP LK SCR 3.5HEX 4.75X15 ST, UDI #: (B)(4). 180551, LOT 372480, COMP LK SCR 3.5HEX 4.75X20 ST, UDI #: (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE EVALUATED BY MFR: DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL CAUSING THE PATIENT GLENOID TO FRACTURE AND THE CONSTRUCT TO PULL AWAY. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505689 COMP LK SCR 3.5HEX 4.75X15 ST BONE, FIXATION, SCREW KWS ZIMMER BIOMET, INC. 432280

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other