BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVECARE+SFT SYSTEM

    MDR report key: 8583757 · Received May 6, 2019

    Report

    Report Number
    0001526350-2019-00327
    Event Type
    Injury
    Date Received
    May 6, 2019
    Date of Event
    April 9, 2019
    Report Date
    June 6, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    JOW
    PMA / PMN Number
    K151377
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). D2 DEVICE PRODUCT CODE JOW .D4 UDI# (B)(4). THE DEVICE HISTORY RECORD (DHR) OF ACTIVECARE+SFT UNIT SERIAL NUMBER (B)(4). WAS REVIEWED AND NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD) OR ANY OTHER ISSUES WITH THE REPAIR. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AFTER REPAIR AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. ON (B)(6) 2019, IT WAS REPORTED THAT LEG AND FOOT WERE SWOLLEN AND THERE WAS NO ADDITIONAL INFORMATION PROVIDED. DURING EVALUATION SERVICE TECHNICIAN COULDN'T DUPLICATE THE CONCERN OF REPORTED EVENT BUT NOTED THE BELOW MENTIONED ERRORS WITH THE DEVICE. AIR LEAK FROM ONE WAY VALVE (OWV) AND IT WAS DIRTY. THE SERVICE TECHNICIAN THEN REPLACED THE BELOW MENTIONED COMPONENTS FOR THE DEVICE AND CONFIRMED THAT THE DEVICE WAS FUNCTIONING AS INTENDED, RETURNED AS PER ZPC 5.3400, REV 02. THE DEVICE WAS TESTED, INSPECTED, REPAIRED AS PER INVESTIGATION RESULTS AND REPAIR MCS, ZPC 7.7008/A REV 01. CHECK VALVE (318B001901). SQUARE WARRANTY SEAL (350W000102). TWIST LOCK (405K602000). THE SERVICE TECHNICIAN WAS NOT ABLE TO REPRODUCE THE REPORTED EVENT WITH THE DEVICE DURING EVALUATION BUT MALFUNCTION OF ONE WAY VALVE (OWV) MIGHT BE A CAUSE FOR THIS EVENT. THEREFORE, BASED ON THE INFORMATION PROVIDED, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER REPLACING WITH CHECK VALVE, SQUARE WARRANTY SEAL AND TWIST LOCK. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    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). ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEG AND FOOT WERE VERY SWOLLEN. THE EVENT TIMING WAS UNKNOWN. NO ADDITIONAL CONSEQUENCES HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376100 ACTIVECARE+SFT SYSTEM SLEEVE, LIMB, COMPRESSIBLE JOW ZIMMER SURGICAL, INC. 63985136

    Patients

    Seq Age Sex Outcome Treatment
    1 Other