BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO II MOD ENDO HEAD SZ 44

    MDR report key: 7336390 · Received March 13, 2018

    Report

    Report Number
    0001825034-2018-01757
    Event Type
    Injury
    Date Received
    March 13, 2018
    Date of Event
    September 1, 2011
    Report Date
    April 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWL
    PMA / PMN Number
    PK984028
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING REPORT IS SUBMITTED TO RELAY CORRECT AND ADDITIONAL INFORMATION RECEIVED. CONCOMITANT MEDICAL PRODUCTS : 139246  ENDO II TAPER INSERT +3MM T1 937440 , 12-162615 COCR INTEGRAL CENTR 15X155MM 608770 , EP-108625 E-POLY 44MM +3 MROM LNR SZ25 008450 . THE REPORTED EVENT IS CONFIRMED BASED ON THE SURGICAL NOTES THAT WAS PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND IDENTIFIED NO DEVIATIONS OR ANOMALIES. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: 11-300816, ARCOS 16X150MM SPL TPR DIST, 523080, 139254, M2A-MAGNUM 42-50MM TPR INSRT-3, 965000, 157444, M2A-MAGNUM MOD HD SZ 44MM, 006080, UNKNOWN, STRYKER TITANIUM CUP, UNKNOWN, UNKNOWN, 6.5 SCREW LENGTH 35, 35, 24 MM, UNKNOWN, UNKNOWN, STRYKER X3 LINER, UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 - 2018 - 01755, 0001825034 - 2018 - 01756, 0001825034 - 2018 - 01758. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BLOOD LOSS OF 1500CC DURING A STAGE II REVISION PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177403 ENDO II MOD ENDO HEAD SZ 44 PROSTHESIS, HIP KWL ZIMMER BIOMET, INC. N/A 431060

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| O