BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° X3 INSERT 36MM ID

    MDR report key: 2982711 · Received February 28, 2013

    Report

    Report Number
    0002249697-2013-00819
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 3, 2013
    Report Date
    February 5, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISLOCATION INVOLVING A TRIDENT 0° X3 INSERT 36MM ID WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. A COMPLAINT HISTORY REVIEW CONFIRMED NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT WAS AT HOME FOLLOWING REVISION SURGERY WAS SITTING ON A PILLOW, TURNED AND FELT A "POP". PATIENT WAS NOT IN PAIN BUT DID HAVE DIFFICULTY WALKING AND DECIDED TO GO TO THE CLINIC WHERE IT WAS DISCOVERED THAT THEIR HIP WAS DISLOCATED.

    Description of Event or Problem · 1

    PATIENT WAS AT HOME FOLLOWING REVISION SURGERY WAS SITTING ON A PILLOW, TURNED AND FELT A "POP". PATIENT WAS NOT IN PAIN BUT DID HAVE DIFFICULTY WALKING AND DECIDED TO GO TO THE CLINIC WHERE IT WAS DISCOVERED THAT THEIR HIP WAS DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86812 TRIDENT 0° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MMAT2M

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| O| R