BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 10° X3 INSERT 36MM ID

    MDR report key: 3261713 · Received August 2, 2013

    Report

    Report Number
    0002249697-2013-02503
    Event Type
    Malfunction
    Date Received
    August 2, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) CENTIMETERS IN HEIGHT. AN EVENT REGARDING ASSEMBLY ISSUE INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS: INDENTATIONS WERE OBSERVED ON THE ARTICULATING SURFACE AND AROUND THE PROXIMAL RIM. THESE DAMAGES ARE CONSISTENT WITH AN IMPLANTATION ATTEMPT. NO OTHER NOTABLE FEATURES WERE OBSERVED ON THE DEVICE. DIMENSIONAL INSPECTION: THE DEVICE WAS DIMENSIONALLY WITHIN SPECIFICATION WITH THE EXCEPTION OF FOUR FEATURES. HOWEVER, THE DAMAGES OBSERVED COULD NOT HAVE OCCURRED DURING MANUFACTURE. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED. FURTHER INFORMATION SUCH AS PATIENT DETAILS, OPERATIVE REPORTS WOULD BE HELPFUL IN INVESTIGATING THIS EVENT FURTHER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IN THE FELLOWSHIP AT (B)(6) HOSPITAL DURING THE SURGERY, A 36 G X3 LINING (NEW PRODUCT) COULDN'T BE INSTALLED TO TRIDENT MORTAR ON THE CUP. THE DOCTOR MADE MANY ATTEMPTS IN SURGERY BUT HAS NOT BEEN SUCCESSFUL. AFTER THE DOCTOR CHANGED TO THE SAME TYPE OF X3 LINING AND IT WAS SUCCESSFUL.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IN THE FELLOWSHIP AT (B)(6) HOSPITAL DURING THE SURGERY, A 36 G X3 LINING (NEW PRODUCT) COULDN'T BE INSTALLED TO TRIDENT MORTAR ON THE CUP. THE DOCTOR MADE MANY ATTEMPTS IN SURGERY BUT HAS NOT BEEN SUCCESSFUL. AFTER THE DOCTOR CHANGED TO THE SAME TYPE OF X3 LINING AND IT WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362186 TRIDENT 10° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH 34895901

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other