BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULS PLUS AC HIP KIT

    MDR report key: 9370470 · Received November 25, 2019

    Report

    Report Number
    0001526350-2019-01068
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    November 6, 2019
    Report Date
    December 26, 2019
    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). 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 FELL INTO THE FEMUR AND HAD TO BE SEARCHED OUT BY THE STAFF AND REMOVED. THE DEVICE HISTORY RECORD (DHR) FOR 00515048601, COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THE REPORTED EVENT. ON 11 NOVEMBER 2019, IT WAS REPORTED FROM KREISKLINIKUM SIEGEN GMBH THAT THAT A PLASTIC PART HAD FALLED OFF OF THE FRONT OF THE RADIAL SPRAY ATTACHMENT AND INTO THE FEMORAL CAVITY OF A PATIENT. 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. THE REPORTED EVENT COULD NOT BE CONFIRMED AND NO FURTHER ANALYSIS COULD BE COMPLETED ON THE DEFECT AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THEREFORE, BASED ON THE INFORMATION PROVIDED, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. REVIEW OF THE INFORMATION PROVIDED DURING THE INVESTIGATION DETERMINED THERE IS NO FURTHER ACTIONS NEEDED AT THIS TIME (IE/CAPA/SCAR/HHE/D). THIS COMPLAINT WILL BE TRACKED AND TRENDED FOR ANY ADVERSE TRENDS THAT MAY WARRANT FURTHER ACTION.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). UPON RECEIPT OF ADDITIONAL INFORMATION, THE PRODUCT RETURN AND THE INVESTIGATION IS COMPLETE, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED. DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PROBLEM WITH RADIAL SPRAY ATTACHMENT (LONG NECK).DURING SURGERY THE RADIAL SPRAY ATTACHMENT HAS FALLEN OFF AT THE FRONT (WHERE THE LIQUID COMES OUT). THE PLASTIC PART CAME OFF AND FELL INTO THE FEMUR AND HAD TO BE SEARCHED OUT BY THE STAFF AND REMOVED. THERE WAS NO HARM TO THE PATIENT AND NO DELAY CAUSED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166049 PULS PLUS AC HIP KIT DISPOSABLE LINE-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM FQH ZIMMER SURGICAL, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1