BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° X3 INSERT 36MM ID

    MDR report key: 4123234 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03624
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    June 10, 2014
    Report Date
    September 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) CENTIMETERS IN HEIGHT. AN EVENT REGARDING DISLOCATION INVOLVING A TRIDENT 0° X3 INSERT 36MM ID WAS REPORTED. THE EVENT WAS CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL INFORMATION BY A CLINICAL CONSULTANT CONCLUDED "IN THIS CASE, THE PATIENT-RELATED FACTOR OF AN ADVERSE MOVEMENT IN THE HIP WAS PRINCIPAL WITH AN UNPROTECTED STATUS OF THE HIP CAPSULE EARLY AFTER SURGERY AS FACILITATING FACTOR AND AS SUCH ROOT CAUSE OF FAILURE IS NOT DEVICE-RELATED." 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 SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: A MEDICAL REVIEW WAS PERFORMED AND DID NOT INDICATE ANY EVIDENCE TO SUGGEST A DEVICE RELATED ISSUE.

    Description of Event or Problem · 1

    THE CRA REPORTED ON BEHALF OF THE CUSTOMER THAT A (B)(6) YEAR OLD MALE PATIENT WHO HAD UNDERGONE A THAT ON (B)(6) 2014 WITH AN ACCOLADE / TRIDENT COMBINATION PRESENTED TO THE EMERGENCY ROOM WITH AN ALLEGED DISLOCATION OF THE HIP AND THAT THIS WAS TREATED SUCCESSFULLY BY A CLOSED REDUCTION ON RECOVERY ON (B)(6) 2014.

    Description of Event or Problem · 1

    THE CRA REPORTED ON BEHALF OF THE CUSTOMER THAT A (B)(6) MALE PATIENT WHO HAD UNDERGONE A THA ON (B)(6) 2014 WITH AN ACCOLADE / TRIDENT COMBINATION PRESENTED TO THE EMERGENCY ROOM WITH AN ALLEGED DISLOCATION OF THE HIP AND THAT THIS WAS TREATED SUCCESSFULLY BY A CLOSED REDUCTION ON RECOVERY ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602950 TRIDENT 0° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH 40979701

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R