BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURPASS ACETABULAR SHELL LINER

    MDR report key: 1372272 · Received February 16, 2009

    Report

    Report Number
    2530191-2009-00002
    Event Type
    Malfunction
    Date Received
    February 16, 2009
    Date of Event
    January 22, 2009
    Report Date
    January 12, 2009
    Manufacturer
    STELKAST, INC
    Product Code
    MRA
    PMA / PMN Number
    P040051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD FOR THE SURPASS ACETABULAR SHELL LINER, LOT NUMBER 19565-013008 SHOWED THAT A TOTAL PIECES WERE PRODUCED AND THAT NO MATERIAL PROPERTY, MECHANICAL, OR DIMENSIONAL DISCREPANCIES EXISTED IN THE PRODUCTION OF THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE MATING PART USED IN SURGERY, SURPASS 50MM ACETABULAR SHELL, LOT NUMBER 19918-082508 WAS CONDUCTED AND SHOWED THAT NO MATERIAL PROPERTY, MECHANICAL, OR DIMENSIONAL DISCREPANCIES EXISTED IN THE MANUFACTURING OF THIS DEVICE. A REVIEW OF THE COMPLAINT LOG SHOWED THAT THERE HAVE BEEN NO OTHER INCIDENTS RELATED TO THIS PARTICULAR DEVICE OR OTHER VARIATIONS. TO DATE, THERE HAVE BEEN A TOTAL ACETABULAR SHELL LINERS IMPLANTED. SOME OF THESE LINERS ARE OF THE DESIGN. THERE HAVE BEEN NO TRENDS RELATED TO THIS TYPE OF INCIDENT. CONCLUSION: THE CAUSE OF THE FRACTURE AFTER IMPACTION COULD NOT BE DETERMINED BASED ON THE GIVEN EVIDENCE. THERE IS PUBLISHED LITERATURE THAT SUPPORTS THE PROBABILITY OF FRACTURE IF THE LINER IS CANTED AND WEDGED INTO THE SHELL BEFORE IMPACT. STELKAST INSTRUCTIONS FOR USE, WHICH IS PACKAGED WITH EACH LINER, WARNS THAT THIS TYPE OF EVENT CAN OCCUR.

    Description of Event or Problem · 1

    DURING TRIAL PROCEDURE, IMPERFECTIONS WERE NOTED IN THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURPASS ACETABULAR SHELL LINER MRA STELKAST, INC 19565-013008

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention