BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA V40-FEMORAL HEAD 32MM, -4MM NK

    MDR report key: 3925585 · Received July 10, 2014

    Report

    Report Number
    0002249697-2014-02606
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    January 27, 2006
    Report Date
    June 13, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K023901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DEVICE DEGENERATION INVOLVING AN ALUMINA FEMORAL HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: THE REPORTED DEVICE WAS ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW NOT PERFORMED AS A REASON FOR REVISION WAS NOT PROVIDED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO ONGOING LITIGATION. LOT NUMBERS 11736001 AND 15979001 WERE NOTED IN THIS REPORT BUT IT IS NOT CLEAR WHICH, IF EITHER OF THESE LOTS, WERE INVOLVED WITH THE PATIENT'S REVISION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS STILL UNKNOWN. DEVICE HISTORY REVIEW: THE REPORTED DEVICE WAS ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND / OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY FOR THE PATIENT AS A RESULT OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT HIP SURGERY USING TRIDENT ACETABULAR CERAMIC ON CERAMIC HIP SYSTEM ON (B)(6) 2006. IT IS ALLEGED "HER PROSTHETICS HAD DEGENERATED". THE PATIENT HAD REVISION SURGERY ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY FOR THE PATIENT AS A RESULT OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT HIP SURGERY USING TRIDENT ACETABULAR CERAMIC ON CERAMIC HIP SYSTEM ON (B)(6) 2006. IT IS ALLEGED "HER PROSTHETICS HAD DEGENERATED". THE PATIENT HAD REVISION SURGERY ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY FOR THE PATIENT AS A RESULT OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT HIP SURGERY USING TRIDENT ACETABULAR CERAMIC ON CERAMIC HIP SYSTEM ON (B)(6) 2006. IT IS ALLEGED "HER PROSTHETICS HAD DEGENERATED". THE PATIENT HAD REVISION SURGERY ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404095 ALUMINA V40-FEMORAL HEAD 32MM, -4MM NK IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 11736001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R