BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 6910151 · Received October 3, 2017

    Report

    Report Number
    0001825034-2017-07802
    Event Type
    Injury
    Date Received
    October 3, 2017
    Report Date
    October 3, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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. ARTICLE:COMPARISON OF THE RISK OF REVISION IN CEMENTLESS TOTAL HIP ARTHROPLASTY WITH CERAMIC-ON-CERAMIC AND METAL-ON-POLYETHYLENE BEARINGS DATA ON 11,096 PATIENTS FROM THE DANISH HIP ARTHROPLASTY REGISTRY CLAUS VARNUM1,2,3, ALMA B PEDERSEN4, PER KJÆRSGAARD-ANDERSEN3, AND SØREN OVERGAARD1,2 (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "COMPARISON OF THE RISK OF REVISION IN CEMENTLESS TOTAL HIP ARTHROPLASTY WITH CERAMIC-ON-CERAMIC AND METAL-ON-POLYETHYLENE BEARINGS" WHICH AIMED TO COMPARE THE 9-YEAR REVISION RISK FOR CEMENTLESS COC TOTAL HIP ARTHROPLASTY AND FOR CEMENTLESS MOP TOTAL HIP ARTHROPLASTY. ACTA ORTHOPAEDICA 2015; 86 (3) VARNUM, CLAUS ET AL. THIS COMPLAINT REPRESENTS: (6) DEEP INFECTION RESULTING IN REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690700 UNKNOWN HIP PROSTHESIS HIP JWH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R