BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEONICS C-TAPER ZIRCONIA HD

    MDR report key: 3011204 · Received March 19, 2013

    Report

    Report Number
    0002249697-2013-01029
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K925695
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4): NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DEVICE FRACTURE INVOLVING A ZIRCONIA HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. NO ITEMS WERE RETURNED FOR INSPECTION. NO MEANINGFUL PATIENT INFORMATION WAS PROVIDED. LOT WAS UNKNOWN. THE COMPLAINT DATABASES WERE REVIEWED FROM 1999 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING ZIRCONIA HEAD FRACTURE. THERE HAVE BEEN OTHER REPORTED EVENTS FOR THIS PRODUCT FAMILY RELATING TO THE PRODUCT RECALL. THE SUPPLIER RECALL IDENTIFIED SEVERAL SPECIFIC "SUSPECT" BATCHES THAT HAVE HAD REPORTED FRACTURE OR PROCESS DEVIATIONS ASSOCIATED WITH A NEW HEAT TREAT TUNNEL PROCESS IN RESPONSE TO THIS, HOWMEDICA OSTEONICS ISSUED A RECALL FOR ALL ZIRCONIA PRODUCT SINCE 1998. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND / OR INSUFFICIENT INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    ZIRCONIA C-TAPER HEAD FRACTURED.

    Description of Event or Problem · 1

    ZIRCONIA C-TAPER HEAD FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114272 OSTEONICS C-TAPER ZIRCONIA HD IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention