BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIZE 6 ACCOLADE II 132 DEG

    MDR report key: 3010122 · Received March 19, 2013

    Report

    Report Number
    0002249697-2013-01012
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    October 10, 2012
    Report Date
    March 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K120578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE, MEDICAL RECORDS AND X-RAYS WOULD NOT BE PROVIDED FOR EVALUATION DUE TO HOSPITAL POLICY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EVENT WAS NOT CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED, HOWEVER IT IS STATED IN THE EVENT DESCRIPTION THAT THE PATIENT UNDERWENT REVISION SURGERY 2 DAYS POST INITIAL SURGERY AND A TRAUMATIC EVENT WAS REPORTED (I.E. PATIENT FELL). THEREFORE THE TRAUMATIC EVENT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY & REVISION OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND / OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS.

    Description of Event or Problem · 1

    THE PATIENT WAS DISCHARGED TO HOME FOLLOWING PRIMARY RIGHT THA. PATIENT FELL IN HOME ON (B)(6) 2012 AND WAS TOLD TO GO TO THE EMERGENCY ROOM IF UNABLE TO WEIGHT-BEAR OR PAIN WAS UNBEARABLE. PATIENT RETURNED TO THE OR ON (B)(6) 2012 AND WAS REVISED.

    Description of Event or Problem · 1

    THE PATIENT WAS DISCHARGED TO HOME FOLLOWING PRIMARY RIGHT THA. PATIENT FELL IN HOME ON (B)(6) 2012 AND WAS TOLD TO GO TO THE EMERGENCY ROOM IF UNABLE TO WEIGHT-BEAR OR PAIN WAS UNBEARABLE. PATIENT RETURNED TO THE OR ON (B)(6) 2012 AND WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113660 SIZE 6 ACCOLADE II 132 DEG IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 40542701

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| O| R