BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MAGNUM SHELL

    MDR report key: 7634539 · Received June 25, 2018

    Report

    Report Number
    0001825034-2018-04250
    Event Type
    Injury
    Date Received
    June 25, 2018
    Date of Event
    September 24, 2017
    Report Date
    June 25, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CONCOMITANT MEDICAL PRODUCT-UNKNOWN FEMORAL HEAD; UNKNOWN TAPERLOC FEMORAL STEM; UNKNOWN ACTIVE ARTICULATION BEARING REPORT SOURCE: LITERATURE HWANG, JI-HYO, ET AL. ¿DISLOCATIONS AFTER USE OF DUAL-MOBILITY CUPS IN CEMENTLESS PRIMARY TOTAL HIP ARTHROPLASTY: PROSPECTIVE MULTICENTRE SERIES.¿ INTERNATIONAL ORTHOPAEDICS, VOL. 42, NO. 4, JULY 2017, PP. 761¿767., DOI:10.1007/S00264-017-3660-6. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-02761. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE JOURNAL ARTICLE THAT PERIPROSTHETIC FRACTURE OCCURRED IN THREE HIPS FOLLOWING TOTAL HIP ARTHROPLASTY. PATIENTS WERE TREATED BY OPEN REDUCTION INTERNAL FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476942 UNKNOWN MAGNUM SHELL PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R