BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL

    MDR report key: 3023691 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01090
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN CUP. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. MINIMAL PATIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW BUT REJECTED AS THEY WERE INSUFFICIENT FOR DETERMINING A ROOT CAUSE. THE EVENT COULD NOT BE CONFIRMED. THE EXACT ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED DUE TO MINIMAL INFORMATION PROVIDED; HOWEVER, THE EVENT DESCRIPTION DOES SUGGEST IT IS LIKELY DUE TO SURGICAL TECHNIQUE. FURTHER INFORMATION SUCH AS REVISION OPERATIVE REPORTS AND EXAMINATION OF EXPLANTED COMPONENTS WOULD BE REQUIRED IN DETERMINING A ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A CUP REVISION ON LEFT SIDE. CUP WAS REVISED BECAUSE THE CUP WASN'T IN GOOD POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A CUP REVISION ON LEFT SIDE. CUP WAS REVISED BECAUSE THE CUP WASN'T IN GOOD POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126971 TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 36594902

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention