BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM

    MDR report key: 3051296 · Received April 10, 2013

    Report

    Report Number
    0002249697-2013-01245
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED BY SURGEON AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4): NOT RETURNED TO THE MANUFACTURER.

    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. VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A RIGHT PRIMARY TOTAL HIP ON PATIENT WHO HAD PROTRUSIO HIP. THE SURGEON COULD NOT GET A GOOD FIT ON FIRST TWO CUPS THAT SURGEON OPENED FOR THE SURGERY AND SURGEON OPENED A THIRD CUP AND IT WORKED FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A RIGHT PRIMARY TOTAL HIP ON PATIENT WHO HAD PROTRUSIO HIP. THE SURGEON COULD NOT GET A GOOD FIT ON FIRST TWO CUPS THAT SURGEON OPENED FOR THE SURGERY AND SURGEON OPENED A THIRD CUP AND IT WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148364 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MMAK89

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other