BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 3120495 · Received May 20, 2013

    Report

    Report Number
    0002249697-2013-01718
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MRA
    PMA / PMN Number
    P000013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING SQUEAKING, DISLOCATION, AND FRACTURE INVOLVING A TRIDENT ALUMINA INSERT WAS REPORTED. THE DISLOCATION AND FRACTURE WERE CONFIRMED. THE SQUEAKING WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO DEVICE WAS RETURNED. A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED, ¿REPEATED SUBLUXATIONS WITH METAL TRANSFER MAY HAVE CAUSED THE SQUEAKING NOTED IN THE EVENT DESCRIPTION AND A TRAUMATIC DISLOCATION MAY HAVE CAUSED A FRACTURE OF ONE OF BOTH ALUMINA COMPONENTS IN THIS CASE. MORE INFORMATION IS REQUIRED TO EVALUATE THIS CASE.¿ DEVICE HISTORY REVIEW. A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW. A COMPLAINT HISTORY REVIEW CONFIRMED NO OTHER EVENTS FOR THE REPORTED LOT CODE. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT HIP REVISION. PATIENTS HIP WAS SQUEAKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT HIP REVISION. PATIENTS HIP WAS SQUEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222696 TRIDENT ALUMINA INSERT IMPLANT MRA STRYKER ORTHOPAEDICS-MAHWAH 17938701

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| O| R