BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO II TAPER INSERT +6MM T1

    MDR report key: 7802858 · Received August 21, 2018

    Report

    Report Number
    0001825034-2018-08313
    Event Type
    Injury
    Date Received
    August 21, 2018
    Date of Event
    August 2, 2012
    Report Date
    January 7, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWL
    PMA / PMN Number
    PK98408
    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 COMPLAINT IS CONFIRMED BASED ON THE OPERATIVE RECORDS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES WOULD CONTRIBUTE TO REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 12-139012 ENDO II MOD ENDO HEAD SZ 44 708590, CP152445 BI-METRIC FMRL C INTLK 9X300 L 890090, 11-165103 ARCOM RNGLC TRI- POLAR LNR SZ27 190020. THE COMPLAINT IS UNDER INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-08311, 0001825034-2018-08315, 0001825034-2018-08316.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLOOD LOSS OF 1500 ML DURING RE-IMPLANTATION, FOLLOWING TREATMENT OF INFECTION. NO OTHER ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644742 ENDO II TAPER INSERT +6MM T1 PROSTHESIS, HIP KWL ZIMMER BIOMET, INC. N/A 637370

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other