BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 40MM/+4

    MDR report key: 3092446 · Received May 3, 2013

    Report

    Report Number
    0002249697-2013-01532
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K061434
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4): NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALTR INVOLVING A V40 COCR LFIT HEAD 40MM/+4 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. A MATERIAL ANALYSIS REPORT CONCLUDED, ¿THE MACHINED TAPERED SURFACE OF THE V40 LFIT HEAD EXHIBITED EVIDENCE OF SCRATCHES FROM THE EXPLANTATION PROCESS AS WELL AS MICRO-MOTION DAMAGE AND CORROSION DEBRIS INDICATIVE OF A MECHANICALLY ASSISTED CORROSION PROCESS. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE V40 LFIT HEAD.¿ A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. A COMPLAINT HISTORY REVIEW CONFIRMED NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT HAD ADVERSE LOCAL TISSUE REACTION. DR. (B)(6), REVISED PATIENT'S LEFT HIP. A 36 C-TAPER BIOLOX HEAD AND V40 TO C-TAPER ADAPTER.

    Description of Event or Problem · 1

    PATIENT HAD ADVERSE LOCAL TISSUE REACTION. DR. (B)(6) REVISED PATIENT'S LEFT HIP. THE 36 C-TAPER BIOLOX HEAD AND V40 TO C-TAPER ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194045 V40 COCR LFIT HEAD 40MM/+4 IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MHK128

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention