BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 36MM/0

    MDR report key: 3071402 · Received April 22, 2013

    Report

    Report Number
    0002249697-2013-01358
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K022077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION AND CORROSION INVOLVING A V40 COCR LFIT HEAD WAS REPORTED. THE EVENT REPORTING CORROSION WAS CONFIRMED. THE INFECTION WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: MATERIAL ANALYSIS CONFIRMED THE CORROSION. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED. VISUAL INSPECTION: DARK DISCOLORATION, ADHERED DEBRIS AND MATERIAL LOSS WERE OBSERVED THROUGHOUT REGIONS OF THE TAPER. MEDICAL RECORDS RECEIVED AND EVALUATION: "AFTER FOUR-AND-A-HALF YEARS IN SITU, SOME CORROSION PRODUCTS ARE EXPECTED AT THE HEAD TRUNNION JUNCTION AND ARE NOT COMMONLY ASSOCIATED WITH CLINICAL PROBLEMS. THIS REVISION FOR INFECTION WAS NOT RELATED TO THE CORROSION PRODUCTS DESCRIBED." DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. ADDITIONALLY, A REVIEW OF THE STERILITY RECORDS SHOWED THAT THE STERILE LOT WAS WITHIN SPECIFICATION. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT OR STERILE LOT. CONCLUSIONS: THE EXACT CAUSE OF THE INFECTION COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. A MEDICAL REVIEW OF THE X RAY COPIES DATED THE (B)(6) 2013 DID NOT IDENTIFY ANY INFECTION. ADDITIONAL INFORMATION, INCLUDING AN OPERATIVE REPORT OF THE REVISION SURGERY, PROGRESS NOTES, AND X-RAYS NEARER THE DATE OF EXPLANT ARE NEEDED TO FULLY INVESTIGATE THE EVENT. THE CORROSION WAS CONFIRMED. THE MEDICAL REVIEW INDICATED: AFTER FOUR-AND-A-HALF YEARS IN SITU, SOME CORROSION PRODUCTS ARE EXPECTED AT THE HEAD TRUNNION JUNCTION AND ARE NOT COMMONLY ASSOCIATED WITH CLINICAL PROBLEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON DID A REVISION OF RIGHT HIP TODAY OF INFECTED JOINT. FOUND CORROSION ON AND BELOW TRUNION. REMOVED ALL FOUR PIECES AND PUT IN ANTIBIOTIC SPACERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON DID A REVISION OF RIGHT HIP TODAY OF INFECTED JOINT. FOUND CORROSION ON AND BELOW TRUNION. REMOVED ALL FOUR PIECES AND PUT IN ANTIBIOTIC SPACERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171454 V40 COCR LFIT HEAD 36MM/0 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH REXMJE

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| O| R