BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT

    MDR report key: 10264126 · Received July 13, 2020

    Report

    Report Number
    0001822565-2020-02506
    Event Type
    Malfunction
    Date Received
    July 13, 2020
    Date of Event
    June 17, 2020
    Report Date
    October 2, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K161830
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, D4, G4, H2, H3, H6, H10. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. UPON VISUAL EVALUATION IT WAS NOTED THAT WHITE DEBRIS WAS ON THE IMPLANT. THE WHITE FOAM INSERT RETAINING THE IMPLANT IS DAMAGED WHERE THE PROXIMAL END OF THE DEVICE IS LOCATED. THE POLY BAG THAT CONTAINED THE IMPLANT SHOWS ABRASION DAMAGE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO TRANSIT DAMAGE. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED. (01)00889024131934(17)120917(10)62169811.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP SURGERY IT WAS NOTED THAT THE STERILE PACKAGING WAS RIPPED AND STYROFOAM BALLS WERE FOUND ON IMPLANT. A FIVE-MINUTE DELAY WAS REPORTED AND THE SURGEON WAS ABLE TO COMPLETE SURGERY WITH A NEW DEVICE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732857 FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. NI 62169811

    Patients

    Seq Age Sex Outcome Treatment
    1