BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3070775 · Received April 22, 2013

    Report

    Report Number
    0002249697-2013-01347
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN CERAMIC HEAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT CONFIRMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION AND NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE DEVICE WAS NOT PROPERLY IDENTIFIED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES AND THE RETURN OF THE DEVICES ARE NEEDED TO COMPLETE THE INVESTIGATION. THE RESULTS OF THE INVESTIGATION CONCLUDE THERE IS NO INDICATION THE EVENT IS RELATED TO A MANUFACTURING ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE PATIENT HAD A THA (CERAMIC ON CERAMIC) IN 2009. RECENTLY, HER HIP STARTED TO SOUND SQUEAK NOISE AND THE NOISE CHANGED TO RASPING SOUND. THEREFORE, A SURGEON PERFORMED A REVISION THA TO CHECK AND REPLACE A CERAMIC INSERT AND HEAD ON MAR 22. AS A RESULT, THE INSERT WAS CRACKED AND HEAD HAD SOME BLACK SCRATCHES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE PATIENT HAD A THA (CERAMIC ON CERAMIC) IN 2009. RECENTLY, HER HIP STARTED TO SOUND SQUEAK NOISE AND THE NOISE CHANGED TO RASPING SOUND. THEREFORE, A SURGEON PERFORMED A REVISION THA TO CHECK AND REPLACE A CERAMIC INSERT AND HEAD ON (B)(6). AS A RESULT, THE INSERT WAS CRACKED AND HEAD HAD SOME BLACK SCRATCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171169 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R