BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR FEMORAL NECK

    MDR report key: 1346755 · Received March 18, 2009

    Report

    Report Number
    1226188-2009-00002
    Event Type
    Injury
    Date Received
    March 18, 2009
    Date of Event
    March 5, 2009
    Report Date
    March 17, 2009
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    KWY
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL IMPLANTS EXPLANTED: CAT.# 121003, 3X10 FEMORAL STEM, LOT# 159. CAT.# 332835, 28MM +3.5 ALUMINA HEAD, LOT# 234. RESULTS OF INVESTIGATION: THE STEM, NECK , AND NECK BOLT WERE RECEIVED WITH THE MODULAR STEM SEPARATED FROM THE NECK AND HEAD. THE NECK AND HEAD WERE FIRMLY ATTACHED. THERE WAS NO DAMAGE TO THE MODULAR STEM AND NECK JUNCTION. THE PIN WAS INTACT AND UNDAMAGED. THERE WAS EVIDENCE OF BONE INGROWTH INTO THE PLASMA SPRAYED REGION WHICH ALSO SHOWED SURFACE DAMAGE CONSISTENT WITH REMOVAL. THE ONLY NOTABLE DAMAGE WAS TO THE MODULAR NECK, WHICH HAD EXTENSIVE WEAR TO THE AREA JUST BELOW THE TRUNION. THE WEAR WAS MOST LIKELY CAUSED BY IMPINGING ON THE CERAMIC LINER IN THE ACETABULAR CUP (SEE ATTACHED PHOTOGRAPH). THE CERAMIC HEAD EXHIBITED SOME DARK STAINING (SEE ATTACHED PHOTOGRAPH) WHICH IS PROBABLY A RESULT OF METAL PARTICLES TRAPPED BETWEEN THE CERAMIC LINER AND CERAMIC HEAD. OTHER WISE, THERE WAS NO OBSERVABLE DAMAGE TO THE CERAMIC HEAD. A REVIEW OF MANUFACTURING RECORDS FOR THE MODULAR NECK COMPONENT WAS PERFORMED AND THE DIMENSIONS WERE ALL WITHIN TOLERANCE. THE CERTIFICATIONS FOR THE TITANIUM NECK FORGINGS AND MACHINING CONFIRMED THAT THE MODULAR NECK WAS MANUFACTURED TO OMNI SPECIFICATIONS. IN SUMMARY, THE DAMAGE TO THE MODULAR NECK WAS NOT A RESULT FROM DESIGN FLAW OR MANUFACTURING ERROR. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A REVISION FOR CLICKING IN 2009. HE HAD THOUGHT THAT THE STEM WAS LOOSE, BUT FOUND IT WAS NOT. THERE WAS EVIDENCE OF NECK/ACETABULAR LINER IMPINGEMENT WITH THE CERAMIC LINER. THE SURGEON REPLACED THE STEM, NECK AND HEAD. IT WAS REPORTED THAT THE PATIENT WAS RECOVERING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR FEMORAL NECK FEMORAL NECK KWY OMNI LIFE SCIENCE, INC. SHORT 35 333

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R