BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P2 26MM 10DEG INSERT OSTEOLOCK

    MDR report key: 3102209 · Received May 9, 2013

    Report

    Report Number
    0002249697-2013-01584
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K903362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE SURGEON AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RIGHT HIP REVISION WAS DONE, REMOVED LINER AND HEAD DUE TO WEAR OF THE LINER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RIGHT HIP REVISION WAS DONE, REMOVED LINER AND HEAD DUE TO WEAR OF THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203174 P2 26MM 10DEG INSERT OSTEOLOCK IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention