BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP KIT

    MDR report key: 9413680 · Received December 4, 2019

    Report

    Report Number
    0001526350-2019-01115
    Event Type
    Malfunction
    Date Received
    December 4, 2019
    Date of Event
    November 6, 2019
    Report Date
    January 23, 2020
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, D4, E2, E3, G4, G7, H2, H4, H6, H10. D4 UDI: (B)(4). DHR REVIEW: THE DEVICE HISTORY RECORD (DHR) FOR 00515048601 LOT NUMBER 35298523, REVIEW NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. A RETURNED PRODUCT INVESTIGATION COULD NOT BE PERFORMED FOR THE REPORTED EVENT DUE TO THE PRODUCT NOT BEING RETURNED FOR EVALUATION. THE REPORTED EVENT CAN, THEREFORE, NOT BE CONFIRMED. PROBABLE CAUSE/ROOT CAUSE: THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. CONCLUSION: REVIEW OF THE INFORMATION PROVIDED DURING THE INVESTIGATION DETERMINED THERE IS NO FURTHER ACTIONS NEEDED AT THIS TIME. THIS COMPLAINT WILL BE TRACKED AND TRENDED FOR ANY ADVERSE TRENDS THAT MAY WARRANT FURTHER ACTION. H3 OTHER TEXT : DISCARDED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). UPON COMPLETION OF INVESTIGATION A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED PULSAVAC 00-5150-486-01 HIP KIT - PROBLEM WITH RADIAL SPRAY ATTACHMENT (LONG NECK). IN THE CASE OF THE RADIAL SPRAY ATTACHMENT, THIS SMALL PLASTIC PART (SLIGHTLY YELLOWISH AND CROSS-SHAPED) HAS FALLEN OFF AT THE FRONT (WHERE THE LIQUID COMES OUT). THE PLASTIC PART CAME OFF AND LANDED ON THE OPERATING TABLE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208240 HIP KIT LAVAGE, JET FQH ZIMMER SURGICAL, INC. N/A 35298523

    Patients

    Seq Age Sex Outcome Treatment
    1