BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-METRIC/X POR NC 11X135

    MDR report key: 8253234 · Received January 16, 2019

    Report

    Report Number
    0001825034-2019-00163
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Date of Event
    March 7, 2016
    Report Date
    June 26, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS : 139259 M2A MAGNUM 42-50M TPR INSRT +6 070130. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02780. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. REVISION OPERATIVE NOTES STATED THAT THE FEMORAL HEAD COULD NOT BE DISENGAGED FROM THE TRUNNION AS IT WAS COLD WELDED. AN EXTENDED TROCHANTERIC OSTEOTOMY WAS REQUIRED FOR REMOVAL OF THE STEM. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

    IT WAS REPORTED DURING A REVISION PROCEDURE THE TAPER ADAPTER WAS COLD WELDED TO STEM. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 157446, M2A-MAGNUM MOD HD SZ 46MM, 634780. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, [PRODUCT LOCATION UNKNOWN]. THE INVESTIGATION IS IN PROCESS. 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: 0001825034-2019-00161.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A REVISION PROCEDURE THE HEAD WAS COLD WELDED TO STEM. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46460 BI-METRIC/X POR NC 11X135 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 036650

    Patients

    Seq Age Sex Outcome Treatment
    1