BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° X3 INSERT 36MM ID

    MDR report key: 3107662 · Received May 10, 2013

    Report

    Report Number
    0002249697-2013-01626
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    December 24, 2012
    Report Date
    April 19, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS SENT TO PATHOLOGY AS PER HOSPITAL PROTOCOL 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.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISLOCATION INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW FOUND NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THE SUBJECT MANUFACTURING LOT. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED DISLOCATION DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED DUE TO RECURRENT DISLOCATION OF STATUS POST TOTAL HIP REVISION DONE BY DR. (B)(6). DR. (B)(4) DECIDED TO REVISE THE CUP AND LINER TO INCREASE STABILITY OF THE HIP REPLACEMENT. DR. (B)(6) REMOVED THE LINER AND HEAD AND REPLACED THEM WITH A 10 DEGREE HOODED LINER AND A + 7.5 DELTA HEAD.

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED DUE TO RECURRENT DISLOCATION OF STATUS POST TOTAL HIP REVISION DONE BY DR. (B)(6). DR. N. DECIDED TO REVISE THE CUP AND LINER TO INCREASE STABILITY OF THE HIP REPLACEMENT. DR. N. REMOVED THE LINER AND HEAD AND REPLACED THEM WITH A 10 DEGREE HOODED LINER AND A + 7.5 DELTA HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207624 TRIDENT 0° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MJM38J

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention