BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X38MM

    MDR report key: 7278331 · Received February 16, 2018

    Report

    Report Number
    0001825034-2018-01078
    Event Type
    Injury
    Date Received
    February 16, 2018
    Date of Event
    June 13, 2013
    Report Date
    May 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK161190
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY THE REVIEW OF OP NOTES AND X-RAYS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03279, 0001825034-2018-01077, 0001825034-2018-01078.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 650-1055 CER BIOLOXD OPTION HD 28MM 190320, 11-301302 ARCOS CON SZ B STD 60MM 084750.  MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED REPORT(S): 0001825034 - 2018 - 01077. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS MULTIPLE DISLOCATIONS AND FAILED MULTIPLE CONSERVATIVE TREATMENTS. INTRA-OPERATIVELY, A GROSSLY UNSTABLE HIP WITH LOTS OF HEMATOMA AS WELL AS A GREATER TROCHANTER FRACTURE WAS IDENTIFIED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119349 ACT ARTIC E1 HIP BRG 28X38MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 041270 

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R