BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT - CERAMIC ON CERAMIC RIGHT HIP

    MDR report key: 2190428 · Received July 28, 2011

    Report

    Report Number
    9616680-2011-00498
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    August 1, 2010
    Report Date
    July 11, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L INFO (X-RAYS, MEDICAL RECORDS, OPERATIVE NOTES, DEVICE DETAILS) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT'S HUSBAND CALLED TO REPORT THAT HIS WIFE'S CERAMIC HIP SHELL IS DISINTEGRATING, BROKEN AND DETERIORATED. WIFE IS SCHEDULED FOR EMERGENCY REVISION SURGERY ON (B)(6) 2011. NO ACTIVITY THAT SHE DID WOULD HAVE CAUSED THE BREAKAGE. FIRST NOTICED PROBLEM IN (B)(6) 2010, HAD PAIN, THE HIP WAS SQUEAKING. PAIN HAS BEEN CONSISTENT AND PRESSURE THE WHOLE TIME AND THEN IN (B)(6) 2011, SHE FELT THAT SOMETHING BROKE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT - CERAMIC ON CERAMIC RIGHT HIP IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention