BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHELL WITH CLUSTER HOLES POROUS 58 MM O.D. SIZE LL

    MDR report key: 8362417 · Received February 22, 2019

    Report

    Report Number
    0001822565-2019-00584
    Event Type
    Injury
    Date Received
    February 22, 2019
    Date of Event
    January 17, 2019
    Report Date
    April 10, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K151448
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER: 00875101336 LOT NUMBER: 64181557 BRAND NAME: XLPE LINER. CATALOG NUMBER: 00877503603 LOT NUMBER: 2962205 BRAND NAME: BIOLOX DELTA HEAD. CATALOG NUMBER: 00771101100 LOT NUMBER: 64145147 BRAND NAME: M/L TAPER STEM. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE SURGEON DECIDED TO REVISE THE CUP ON THE SAME DAY TO CHANGE POSITION OF THE CUP. A DIFFERENT SIZE ACETABULAR CUP WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154973 SHELL WITH CLUSTER HOLES POROUS 58 MM O.D. SIZE LL PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64108751

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R