BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-TAPER COCR LFIT HEAD 28MM/0

    MDR report key: 3031983 · Received April 3, 2013

    Report

    Report Number
    0002249697-2013-01171
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LWJ
    PMA / PMN Number
    K993601
    Adverse Event
    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 NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING SHELL LOOSENING INVOLVING A C-TAPER COCR LFIT HEAD 28MM/0 WAS REPORTED. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 10-MAR-2003 WITH NO REPORTED DISCREPANCIES. THE FEMORAL HEAD DOES NOT INTERFERE WITH THE SHELL/BONE INTERFACE. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP DONE IN 1996. THE CUP HAD WORKED ITSELF LOOSE, BEADING CAME OFF THE BACK OF THE CUP. THE HEAD CAME OFF THE STEM. PATIENT HAD IN CONTINUITY IN ACETABULUM. THEY PLACED A ZIMMER CUP AND CAGE INTO THE ACETABULUM AND THE STEM WAS LEFT IN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP DONE IN 1996. THE CUP HAD WORKED ITSELF LOOSE, BEADING CAME OFF THE BACK OF THE CUP. THE HEAD CAME OFF THE STEM. PATIENT HAD IN CONTINUITY IN ACETABULUM. THEY PLACED A ZIMMER CUP AND CAGE INTO THE ACETABULUM AND THE STEM WAS LEFT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136384 C-TAPER COCR LFIT HEAD 28MM/0 IMPLANT LWJ STRYKER ORTHOPAEDICS-MAHWAH 90195602

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention