BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC/X POR NC 11X135

    MDR report key: 7272674 · Received February 15, 2018

    Report

    Report Number
    0001825034-2018-00572
    Event Type
    Injury
    Date Received
    February 15, 2018
    Date of Event
    December 12, 2017
    Report Date
    February 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK020580
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT MEDICAL PRODUCTS: 139268, M2A-MAGNUM 52-60 MM TPR INS STD, 220840. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-00573.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED REVISION OP NOTES. REVISION OP NOTES CONFIRM PAINFUL METAL ON METAL HIP REVISION. INABILITY TO REMOVE THE HEAD FROM THE STEM WHICH REQUIRED A SPLIT FEMORAL OSTEOTOMY TO REMOVE THE STEM WAS NOTED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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 DURING A REVISION PROCEDURE THE SURGEON NEEDED TO PERFORM AN OSTEOTOMY SINCE THE HEAD AND TAPER DID NOT DISENGAGE FROM THE STEM. A 40 MINUTE DELAY OCCURRED DUE TO THIS INCIDENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117828 BI-METRIC/X POR NC 11X135 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 870090

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R