BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M / L TAPER KINECTIV MODULAR FEMORAL STEM

    MDR report key: 7597274 · Received June 13, 2018

    Report

    Report Number
    0001822565-2018-03198
    Event Type
    Injury
    Date Received
    June 13, 2018
    Date of Event
    May 16, 2018
    Report Date
    June 13, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK063251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - M/L G2 TAPER MODULAR NECK # ITEM 00784802300 LOT 63789800, BIOLOX DELTA FEMORAL HEAD # ITEM 00877503202 LOT 2924376, STANDARD LINER # ITEM 00630505032 LOT 63855902, SHELL WITH CLUSTER HOLES # ITEM 00620205222 LOT 63816375. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PERI-PROSTHETIC FRACTURE 7 DAYS POST LEFT HIP ARTHROPLASTY AND UNDERWENT A REVISION SURGERY 2 DAYS LATER. 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
    441165 M / L TAPER KINECTIV MODULAR FEMORAL STEM PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 63929630

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R