BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE 132 SIZE 4.5

    MDR report key: 2963735 · Received February 15, 2013

    Report

    Report Number
    0002249697-2013-00694
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION RELATED TO A PSEUDOTUMOR INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED, FURTHER INFORMATION IS NEEDED TO DETERMINE ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # MMH-9988-0048, LOT # FM060123, DESCRIPTION: MITCH TRH MD HD SZ 48+0, MANUFACTURER: DEPUY; CAT # MAC-9988-4854, LOT # FM060416, DESCRIPTION: STD MITCH TRH CP SZ 48/54, MANUFACTURER: DEPUY. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. THE REPORTED DEVICE IS NOT AVAILABLE FOR EVALUATION BECAUSE IT REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH A PSEUDO TUMOUR AND RAISED IRON LEVELS IN THEIR BLOOD. THE MITCH CUP AND MITCH MODULAR HEAD WERE REMOVED FROM THE PATIENT. THE ACCOLADE STEM STAYED IN SITU. THE HEAD WAS REPLACED WITH A 32 MM HEAD AND A TRITANIUM REVISION CUP WAS USED WITH A 32 MM POLY LINER.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH A PSEUDO TUMOUR AND RAISED IRON LEVELS IN THEIR BLOOD. THE MITCH CUP AND MITCH MODULAR HEAD WERE REMOVED FROM THE PATIENT. THE ACCOLADE STEM STAYED IN SITU. THE HEAD WAS REPLACED WITH A 32MM HEAD AND A TRITANIUM REVISION CUP WAS USED WITH A 32MM POLY LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68568 ACCOLADE 132 SIZE 4.5 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 16042501

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O| R