BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UHR BIPOLAR 28X46MM

    MDR report key: 7493722 · Received May 8, 2018

    Report

    Report Number
    0002249697-2018-01358
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    April 11, 2018
    Report Date
    July 26, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    UDI-DI
    07613327016956
    PMA / PMN Number
    K173499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING DISASSOCIATION INVOLVING A UHR BIPOLAR COMPONENT WAS REPORTED. CONCLUSION: IT WAS REPORTED THAT THE HEAD WAS NOT SLIDING SMOOTHLY IN THE UHR BIPOLAR CUP. VISUAL INSPECTION OF THE RETURNED DEVICE NOTED THAT DEVICE WAS RETURNED IN USED CONDITION. THE HEAD WAS FOUND ATTACHED WITH THE BIPOLAR COMPONENT. THE LABEL ON THE HEAD WAS OF DIFFERENT MANUFACTURER "MICROPORT". NO MAJOR DAMAGES WERE OBSERVED ON THE DEVICE. BASED ON THE PROVIDED INFORMATION IT HAS BEEN DETERMINED THAT THIS EVENT IS ASSOCIATED WITH AN OFF-LABEL APPLICATION. THE IFU LABEL PACKAGED WITH THE DEVICE INDICATES THAT, "HOWMEDICA OSTEONICS CORP. STRONGLY ADVISES AGAINST THE USE OF ANOTHER MANUFACTURER¿S FEMORAL STEM COMPONENT WITH ANY HOWMEDICA OSTEONICS¿ BIPOLAR COMPONENT. ANY SUCH USE WILL NEGATE THE RESPONSIBILITY OF HOWMEDICA OSTEONICS CORP. FOR THE PERFORMANCE OF THE RESULTING MIXED COMPONENT IMPLANT." NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    IT IS REPORTED THAT A STRYKER HEAD WAS NOT SLIDING SMOOTHLY IN THE UHR BIPOLAR CUP.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES.THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A STRYKER HEAD WAS NOT SLIDING SMOOTHLY IN THE UHR BIPOLAR CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339487 UHR BIPOLAR 28X46MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI STRYKER ORTHOPAEDICS-MAHWAH 3P0D3T 07613327016956

    Patients

    Seq Age Sex Outcome Treatment
    1 Other