BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #1

    MDR report key: 3468103 · Received November 13, 2013

    Report

    Report Number
    0002249697-2013-03671
    Event Type
    Injury
    Date Received
    November 13, 2013
    Date of Event
    April 19, 2008
    Report Date
    October 21, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # MMH-9988-0048, LOT # FM063624, DESCRIPTION: MITCH TRH MD HD SZ 48+0, MANUFACTURER: DEPUY; CAT # MAC-9988-4854, LOT # FM060696, 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 INFORMATION IN THIS REPORT WAS PROVIDED BY FOREIGN ATTORNEY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICES ARE NOT AVAILABLE DUE TO THE ONGOING LITIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INJURIES AND/OR DAMAGES ARISING FROM FAILURE OF THE IMPLANT INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED. THIS EVENT IS UNDER THE SCOPE OF RA 2012-080, INITIATED IN RESPONSE TO THE FIELD SAFETY NOTICE FOR MITCH TRH CUP /HEAD WHEN IMPLANTED WITH THE UNCEMENTED ACCOLADE STEM. A REVIEW OF POST-MARKET SURVEILLANCE DATA SUGGESTED A HIGHER THAN EXPECTED REVISION RATE FOR THIS DEVICE COMBINATION. THE FIELD SAFETY NOTICE ADVISES AGAINST THIS COMBINATION AND RECOMMENDS PATIENTS BE FOLLOWED ACCORDING TO LOCAL GUIDANCE/STANDARD OF CARE FOR PATIENTS RECEIVING METAL ON METAL ARTICULATIONS.

    Description of Event or Problem · 1

    THE SOLICITOR REPORTED THAT A FEMALE PATIENT UNDERWENT AN ACCOLADE / MITCH PROCEDURE ON (B)(6) 2008. THE SOLICITOR NOTED THAT THEY HAVE BEEN INSTRUCTED TO PURSUE PERSONAL INJURIES AND DAMAGES SUFFERED TO THEIR CLIENT DUE TO THE ALLEGED FAILURE OF HER METAL-ON-METAL HIP IMPLANT.

    Description of Event or Problem · 1

    THE SOLICITOR REPORTED THAT A FEMALE PATIENT UNDERWENT AN ACCOLADE / MITCH PROCEDURE ON (B)(6) 2008. THE SOLICITOR NOTED THAT THEY HAVE BEEN INSTRUCTED TO PURSUE PERSONAL INJURIES AND DAMAGES SUFFERED TO THEIR CLIENT DUE TO THE ALLEGED FAILURE OF HER METAL-ON-METAL HIP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587196 ACCOLADE PLUS TMZF HIP STEM #1 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 21499301

    Patients

    Seq Age Sex Outcome Treatment
    1 Other