BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS 28/50

    MDR report key: 2924509 · Received January 22, 2013

    Report

    Report Number
    0002249697-2013-00093
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 22, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K093644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE VERY LIMITED INFORMATION PROVIDED. IT IS UNKNOWN IF AN INTRA-PROSTHETIC DISLOCATION OR A STANDARD DISLOCATION OCCURRED. THE PATIENT IS NOTED TO BE OBESE AND A REVIEW OF THE INSTRUCTIONS FOR USE PACKAGED WITH THIS DEVICE INDICATES THAT IMPLANTING IN OBESE PATIENTS INCREASES THE LIKELIHOOD OF FAILURE. THE REVIEW INDICATED THAT ALL REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. A REVIEW OF THE COMPLAINT DATABASE INDICATES THERE HAVE BEEN NO OTHER REPORTED EVENTS FOR THE REPORTED LOT CODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCTOR REVISED PATIENT'S HIP DUE TO DISLOCATION FROM LACK OF ABDUCTORS PURSUANT TO REVISION SURGERY ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCTOR REVISED PATIENT'S HIP DUE TO DISLOCATION FROM LACK OF ABDUCTORS PURSUANT TO REVISION SURGERY ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29028 RESTORATION ADM X3 INS 28/50 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 37814801

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| O| R