BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/+3MM

    MDR report key: 7406573 · Received April 9, 2018

    Report

    Report Number
    3002806535-2018-00678
    Event Type
    Injury
    Date Received
    April 9, 2018
    Date of Event
    February 17, 2016
    Report Date
    April 5, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PK131684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110003628, BIOLOX DELTA CER LNR 36MM G, UNKNOWN, 010000666, G7 PPS LTD ACET SHELL 58G, 3441482, 51-106140, TPRLC 133 MP TYPE1 PPS SO 14.0, 3242870. REPORT SOURCE, FOREIGN - THE EVENT OCCURRED IN (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION, THEREFORE A VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORT EVENT WAS NOT REPORTED. 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. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. ONE YEAR POST-OP, IT WAS REPORTED THAT THE PATIENT EXPERIENCED MILD PAIN (RARELY MODERATE AFTER UNUSUAL ACTIVITY, AND MAY TAKE ASPIRIN), USES THE SUPPORT OF ONE CRUTCH FOR WALKING, MODERATE TROUBLE WASHING/DRYING, MODERATE TROUBLE GETTING IN OR OUT OF CAR, MODERATE TROUBLE SHOPPING, MODERATELY DIFFICULT TO CLIMB STAIRS, AND LIMPING OFTEN. IT WAS NOTED THAT PAIN HAS MODERATELY INTERFERED WITH THE PATIENT'S USUAL WORK. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250960 DELTA CERAMIC FEM HD 36/+3MM PROSTHESIS, HIP LZO BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other