BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP KIT

    MDR report key: 15372975 · Received September 7, 2022

    Report

    Report Number
    0001526350-2022-00873
    Event Type
    Malfunction
    Date Received
    September 7, 2022
    Date of Event
    May 24, 2022
    Report Date
    September 7, 2022
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FQH
    UDI-DI
    00889024380073
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). TELEPHONE NUMBER: +81-269-22-2151. FUNCTIONAL TESTING FOUND THE DEVICE WOULD NOT POWER ON WITH THE ORIGINAL BATTERY PACK, BUT DID POWER ON WHEN CONNECTED TO A LAB BATTERY PACK. VISUAL INSPECTION OF THE INTERIOR OF THE BATTERY PACK FOUND ONE OF THE BATTERIES HAD LEAKED INSIDE THE PACK. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT IS CONFIRMED. 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

    IT WAS REPORTED THAT DURING THE SURGERY, THIS COMPLAINT PRODUCT DIDN'T WORK. THERE WAS A 0-15 MINUTE DELAY; HOWEVER, THERE WAS NO HARM TO THE PATIENT. DURING EVALUATION HOWEVER, LEAKAGE WAS FOUND FROM ONE OF THE BATTERIES. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2682968 HIP KIT LAVAGE, JET FQH ZIMMER SURGICAL, INC. N/A 64972163 00889024380073

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown