BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX HIP SYSTEM

    MDR report key: 4151965 · Received October 6, 2014

    Report

    Report Number
    1226188-2014-00064
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 8, 2014
    Manufacturer
    OMNLIFE SCIENCE
    Product Code
    LPH
    PMA / PMN Number
    K090845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND A PHYSICAL INVESTIGATION WAS THEN PERFORMED. IN THE DEVICE EVALUATION SUMMARY DATED (B)(4) 2014, IT'S EXPLAINED: THERE WERE THREE SEPARATE COMPONENTS AVAILABLE FOR EXAMINATION: THE EXPLANTED ARC MODULAR FEMORAL STEM, THE ARC MODULAR FEMORAL NECK, AND THE ALUMINA CERAMIC FEMORAL HEAD. ALL THREE COMPONENTS WERE GENERALLY INTACT, WITH NO APPARENT MECHANICAL FRACTURES. THE PROXIMAL CONICAL TAPERED PORTION OF THE COBALT CHROME MODULAR NECK APPEARED LARGELY PRISTINE WITH MINIMAL SURFACE STAINING AND NO FRETTING OR CORROSIVE DAMAGE. THE DISTAL TAPERED NECK-STEM JUNCTION HAD EXTENSIVE BLACK STAINING OF THE FLAT AND CLINICAL TAPERED SURFACES. THESE DEPOSITS ARE CONSISTENT WITH ABRASION AND MATERIAL TRANSFER FROM THE MATING SURFACES OF THE TITANIUM ALLOY STEM. THE MEDIAL/VARUS TAPERED CONICAL SURFACE OF THE NECK HAD SIGNIFICANT BLACK STAINING, SURFACE DAMAGE AND FRETTING CORROSION, WITH THE MOST EXTENSIVE SURFACE DAMAGE LOCATED NEAR THE PROXIMAL END OF THE NECK-STEM JUNCTION. THE PLASMA SPRAYED COASTING ALSO SHOWED SOME MECHANICAL DAMAGE LIKELY SECONDARY TO REMOVAL OF THE DEVICE DURING THE REVISION SURGERY. THERE WAS ALSO SOME STAINING OF THE PROXIMAL END NEAR THE NECK MODULAR JUNCTION CAVITY (TAPERED BORE). THE ALUMINA CERAMIC HEAD IS INTACT AND LARGELY UNDAMAGED WITH THE EXCEPTION OF PATCHY BLACK STAINING OF THE OUTER SURFACE. THE COMPLAINT MADE NO INDICATION OF OMNI PRODUCT BEING RELATED TO MALFUNCTION OR DEFICIENCY. REVIEW OF THE MANUFACTURING AND STERILIZATION DOCUMENTATION REVEALED NO DEVIATIONS.

    Description of Event or Problem · 1

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT HIP REVISION SURGERY ON (B)(6) 2014. THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2011. THE REVISION SURGERY OCCURRED AS A RESULT OF A METAL ALLERGY TO COBALT. THE ORIGINAL ARC STEM WAS REVISED TO A K1 STEM, THE 32MM LINER WAS REPLACED WITH A NEW ONE OF THE SAME SIZE, AND THE CERAMIC HEAD WAS ALSO REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624890 APEX HIP SYSTEM LPH OMNLIFE SCIENCE 9137

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R