BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO II MOD ENDO HEAD SZ 44

    MDR report key: 7802869 · Received August 21, 2018

    Report

    Report Number
    0001825034-2018-08311
    Event Type
    Injury
    Date Received
    August 21, 2018
    Date of Event
    August 2, 2012
    Report Date
    January 8, 2019
    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 BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED 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: 139245 ENDO II TAPER INSERT +6 MM T1 637370, 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: 0001825034-2018-08313, 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
    644955 ENDO II MOD ENDO HEAD SZ 44 PROSTHESIS, HIP KWL ZIMMER BIOMET, INC. N/A 708590

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other