BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS 28/54

    MDR report key: 3023661 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01086
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 4, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K093644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED DISCREPANCIES AND THERE WERE NO OTHER EVENTS FOR THE REFERENCED LOT. THE RETURNED ADM INSERT EXHIBITS EXTENSIVE SCRATCHING AND GOUGING ON THE OUTER ARTICULATING SURFACE AND FACE OF THE DEVICE, WHICH MOST LIKELY OCCURRED DURING EXPLANTATION. THERE IS NO VISUAL DAMAGE TO THE RETAINING RIM OR INNER ARTICULATING SURFACE. THE IDENTIFICATION MARKING ON THE FACE OF THE DEVICE IS NOTED TO BE FADED AND DIFFICULT TO READ. THIS IS INDICATIVE THAT THE COMPONENT WAS EXPOSED TO HIGH TEMPERATURE DECONTAMINATION (SUCH AS AUTOCLAVING). INSUFFICIENT MEDICAL INFORMATION OR RECORDS WAS RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS OPERATIVE REPORTS, XRAYS, PATIENT HISTORY & FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER. THE REPORTED EVENT REGARDING DISLOCATION OF A RESTORATION ADM LINER AND A METAL HEAD 9PR 71540) WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    PATIENT FELL. THE LITTLE BALL DISASSOCIATED FROM THE BIG BALL ADM IMPLANT.

    Description of Event or Problem · 1

    PATIENT FELL. THE LITTLE BALL DISASSOCIATED FROM THE BIG BALL ADM IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126552 RESTORATION ADM X3 INS 28/54 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 34786001

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O| R