BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS FEMORAL STEM

    MDR report key: 4092575 · Received September 4, 2014

    Report

    Report Number
    1822565-2014-01071
    Event Type
    Injury
    Date Received
    September 4, 2014
    Report Date
    August 7, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE. EVALUATION SUMMARY: DESCRIPTION OF RADIOGRAPHS INDICATE THAT THE STEM AND FEMORAL HEAD HAD DISASSOCIATED, AND EXAMINATION OF UNDATED X-RAYS SHOW THE SAME. SEVERE OSTEOLYSIS OF THE GREATER TROCHANTER WAS ALSO NOTED AS WELL AS DEFORMATION OF THE STEM TRUNNION. REVISION SHOWED BLACK STAINED TISSUES, WHICH WAS LIKELY DUE TO THE METAL EROSION OF THE STEM TAPER. IT APPEARS THAT THE FEMORAL HEAD WAS NOT SECURELY MATED WITH THE FEMORAL STEM FOR SOME TIME, AND RESULTED IN EROSION OF THE TAPER AND GENERATION OF METAL DEBRIS. IT WAS ALSO NOTED THAT 2CM OF THE FEMUR WAS ERODED. NEITHER PRIMARY NOR REVISION OPERATIVE NOTES WERE RETURNED FOR REVIEW. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO INFORMATION HAS BEEN RECEIVED TO DATE. WITH THE INFORMATION PROVIDED, IT APPEARS THAT THE FEMORAL HEAD WAS NOT SECURELY MATED WITH THE FEMORAL STEM, WHICH LED TO METAL DEBRIS GENERATION AND SUBSEQUENT TISSUE AND BONE DESTRUCTION. HOWEVER, THE MECHANISM OF FEMORAL HEAD DISASSOCIATION IS UNKNOWN. EVALUATION CODES: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE HEAD DISASSOCIATING FROM THE STEM. DURING THE REVISION SURGERY, CORROSION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541462 VERSYS FEMORAL STEM HIP PROSTHESIS LPH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention UNK ZIMMER FEMORAL HEAD, CATALOG# UNK, LOT# UNK