BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MOM HIP

    MDR report key: 6939648 · Received October 11, 2017

    Report

    Report Number
    0001825034-2017-08446
    Event Type
    Injury
    Date Received
    October 11, 2017
    Report Date
    October 11, 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
    FI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LAINIALA, O., ELO, P., REITO, A., PAJAMAKI, J., PUOLAKKA, T., ESKELINEN, A. (2014) GOOD SENSITIVITY AND SPECIFICITY OF ULTRASOUND FOR DETECTING PSEUDOTUMORS IN 83 FAILED METAL-ON-METAL HIP REPLACEMENTS. ACTA ORTHOPAEDICA 2015; 86(2): X-X. DOI 10.3109/17453674.2014.1001970. SUBMITTED 2014-07-25. ACCEPTED 2014-11-01. THE PRODUCT WAS NOT AVAILABLE FOR RETURN. AVAILABLE INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION TO THE CAUSE OF THE EVENT. PART AND LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY, NEITHER WERE PROVIDED. CONDITION IS ADDRESSED IN THE PACKAGE INSERT. 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. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON A REVIEW OF A JOURNAL ARTICLE TITLED, "GOOD SENSITIVITY AND SPECIFICITY OF ULTRASOUND FOR DETECTING PSEUDOTUMORS IN 83 FAILED METAL-ON-METAL HIP REPLACEMENTS" WHICH AIMED TO EVALUATE THE SENSITIVITY AND SPECIFICITY OF ULTRASOUND (US) FOR DETECTING PSEUDOTUMORS IN A COHORT OF PATIENTS WITH FAILED METAL ON METAL HIP REPLACEMENTS. THIS COMPLAINT REPRESENTS REVISION DUE TO TEN(10) PATIENTS IN WHICH PSEUDOTUMOR WAS FOUND IN BOTH THE ILIOPSOAS AND TROCHANTERIC REGIONS IN TEN (10) HIPS. THERE WAS NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722271 UNKNOWN MOM HIP PROSTHESIS - HIP KWA ZIMMER BIOMET, INC. N/A UNKNOWN LOT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R