BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS

    MDR report key: 3636155 · Received February 20, 2014

    Report

    Report Number
    0002249697-2014-00463
    Event Type
    Injury
    Date Received
    February 20, 2014
    Date of Event
    January 26, 2014
    Report Date
    January 26, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K103233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING DISLOCATION INVOLVING AN ADM X3 LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS: EVALUATION OF THE RETURNED X3 LINER INDICATES THERE ARE SIGNS OF IN VIVO USE, BUT IS OTHERWISE UNREMARKABLE. MEDICAL RECORDS RECEIVED AND EVALUATION: 2 X-RAYS WERE PROVIDED FOR REVIEW. A CONSULTING CLINICIAN INDICATED THE EVENT CANNOT BE CONFIRMED AS THERE IS INSUFFICIENT INFORMATION PROVIDED. DEVICE HISTORY REVIEW: THE REPORTED DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS FURTHER INFORMATION SUCH AS OPERATIVE AND PROGRESSIVE NOTES ARE NEEDED.

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS UNKNOWN MDM LINER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DISLOCATED POST-OP. THE THA DONE (B)(6) 2014. PATIENT WAS REVISED TO CONSTRAINED LINER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DISLOCATED POST-OP. THE THA DONE (B)(6) 2014. PATIENT WAS REVISED TO CONSTRAINED LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108737 RESTORATION ADM X3 INS IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 45980901

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R