BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP NLK SCR 3.5HEX 4.75X15 ST

    MDR report key: 9376179 · Received November 26, 2019

    Report

    Report Number
    0001825034-2019-05144
    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
    KWS
    PMA / PMN Number
    K132239
    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

    (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, 0001825034 - 2019 - 05149. CONCOMITANT MEDICAL PRODUCTS: TAPER ADAPTOR 115310 LOT: 222460, NON-LOCKING SCREWS 180558 LOT:860890, 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, CENTRAL SCREW 115394 LOT 572030. REPORT SOURCE: (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 IS BEING CONSIDERED FOR A REVISION TO ADDRESS GLENOID IMPLANT RELATED BONE LOSS. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172729 COMP NLK SCR 3.5HEX 4.75X15 ST SCREW, FIXATION, BONE KWS ZIMMER BIOMET, INC. N/A 217280

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R