BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL/COMP TI STD TAPER

    MDR report key: 8757590 · Received July 3, 2019

    Report

    Report Number
    0001825034-2019-02726
    Event Type
    Injury
    Date Received
    July 3, 2019
    Date of Event
    June 27, 2013
    Report Date
    July 2, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    K080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE FILED FOR THIS EVENT. PLEASE SEE: 0001825034-2018-05021, 0001825034-2018-05022, 0001825034-2018-05023, 0001825034-2019-02694. CONCOMITANT MEDICAL PRODUCTS: CATALOG # 113648, COMPREHENSIVE PRIMARY STEM 8 MM STD, LOT # 104520. CATALOG # 118001, VERSA-DIAL/COMPREHENSIVE TI STANDARD TAPER, LOT # 201410. CATALOG # XL-115363, ARCOM XL 44-36 STANDARD HUMERAL BEARING, LOT # 011140. CATALOG # 115340, COMPREHENSIVE REVERSE HUMERAL TI TRAY 44 MM, LOT # 492370. CATALOG # 115330, COMPREHENSIVE REVERSE SHOULDER BASEPLATE, LOT # 550050. CATALOG # 180501, FIXED LOCKING SCREW, LOT # 468580. NO DEVICE WAS RETURNED FOR EXAMINATION. MEDICAL RECORDS WERE REVIEWED AND CONFIRMED DEVICE DISASSOCIATION AND DISLOCATION WITH ASSOCIATED METALLOSIS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ROOT CAUSE REMAINS UNDETERMINED. 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

    THE PATIENT WAS REVISED TO ADDRESS DISLOCATION, DISASSOCIATION, AND SUBSEQUENT METALLOSIS. GLENOSPHERE WAS FOUND DISASSOCIATED, SHOULDER DID HAVE SIGNIFICANT DUSKY GREY MATERIAL WHICH WAS CONSISTENT WITH METALLOSIS, AREA WAS WIDE DEBRIDED, AND COPIOUSLY IRRIGATED WITH ANTIBIOTIC IRRIGATION, STEM AND GLENOID BASEPLATE WERE WELL FIXED. NO INTRAOPERATIVE COMPLICATIONS. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550712 VERSA-DIAL/COMP TI STD TAPER PROSTHESIS, EXTREMITY MBF ZIMMER BIOMET, INC. N/A 201410

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R