BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3082029 · Received April 29, 2013

    Report

    Report Number
    0002249697-2013-01459
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    September 20, 2007
    Report Date
    July 11, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING HETEROTOPIC OSSIFICATION INVOLVING AN UNKNOWN TRIDENT SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. A VISUAL, DIMENSIONAL, FUNCTIONAL, OR MATERIAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVISES WERE NOT RETURNED FOR EVALUATION. NO MEDICAL RECORDS WERE RECEIVED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS NO CATALOG OR LOT NUMBER WAS PROVIDED. THE INVESTIGATION CONCLUDED THAT THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION IS NEEDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN SHELL, ACETABULAR TRIDENT PSL SZ 58G. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A HETEROTOPIC OSSIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A HETEROTOPIC OSSIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183629 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R