BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 6954518 · Received October 17, 2017

    Report

    Report Number
    0001825034-2017-08653
    Event Type
    Injury
    Date Received
    October 17, 2017
    Report Date
    October 12, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER AND LOT NUMBER OF THE DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. BOSKER, B. H., ETTEMA, H. B., ROSSUM, M. V., BOOMSMA, M. F., KOLLEN, B. J., MAAS, M., AND VERHEYEN, C. C. (2015). PSEUDOTUMOR FORMATION AND SERUM IONS AFTER LARGE HEAD METAL-ON-METAL STEMMED TOTAL HIP REPLACEMENT. RISK FACTORS, TIME COURSE AND REVISIONS IN 706 HIPS. ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, 135(3), 417-425. DOI:10.1007/S00402-015-2165-2.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "PSEUDOTUMOR FORMATION AND SERUM IONS AFTER LARGE HEAD METAL-ON-METAL STEMMED TOTAL HIP REPLACEMENT. THIS ARTICLE IDENTIFIED FOUR (4) PATIENTS HAD HIP REVISIONS POST THA DUE TO ADVERSE REACTION TO METAL DEBRIS (ARMD). THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735042 UNKNOWN HIP HIP PROSTHESIS KWA ZIMMER BIOMET, INC. NI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R