BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP STEM

    MDR report key: 980255 · Received January 15, 2008

    Report

    Report Number
    1226188-2008-00001
    Event Type
    Injury
    Date Received
    January 15, 2008
    Date of Event
    November 23, 2007
    Report Date
    January 14, 2008
    Manufacturer
    OMNI LIFE SCIENCE INC.
    Product Code
    LPH
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REVISION SURGERY WAS UNEVENTFUL. DESCRIPTION OF COMPLAINT: PT'S ATTORNEY REPORTED THAT "RIGHT HIP PROSTHESIS BROKE" IN 2007, 44 MONTHS AFTER IMPLANTATION. REVISION SURGERY WAS PERFORMED BY DR AT THE HOSPITAL. THE EXPLANTED COMPONENTS WERE STERILIZED AND RETURNED TO OMNI FOR EVAL. RESULTS OF INVESTIGATION: THERE WERE FIVE PIECES AVAILABLE FOR EXAMINATION: THE TITANIUM ALLOY FEMORAL STEM, THE TITANIUM ALLOY MODULAR NECK (2 PIECES, FRACTURED), THE ALUMINA CERAMIC BALL HEAD (ASSEMBLED ON THE NECK), AND THE TITANIUM ALLOY NECK PLUG (ASSEMBLED IN THE NECK). THE COBALT CHROME ALIGNMENT PIN WAS NOT EVIDENT. THE PROXIMAL END OF THE FEMORAL STEM SHOWED EXTENSIVE SURFACE DAMAGE SECONDARY TO SURGICAL REMOVAL OF THE STEM. THE CERAMIC FEMORAL HEAD SHOWED MINOR SURFACE DISCOLORATION BUT WAS OTHERWISE INTACT. THE CERAMIC HEAD WAS FIRMLY SEATED ON THE TRUNNION OF THE NECK. THE NECK PLUG WAS FIRMLY SEATED IN THE NECK AND WAS OTHERWISE UNREMARKABLE. THE MODULAR NECK WAS FRACTURED THROUGH THE MID-PORTION OF THE LATERAL PEG (SEE ATTACHED PHOTO). THE ALIGNMENT HOLES ON THE UNDERSURFACE OF THE NECK AND THE PROXIMAL SURFACE OF THE STEM, WHICH ENGAGE THE COBALT CHROME ALIGNMENT PIN, WERE DEFORMED (SEE ATTACHED PHOTOS). THE SUPERIOR SURFACE OF THE STEM AND INFERIOR SURFACE OF THE NECK WERE SCORED IN A CIRCULAR PATTERN, INDICATING ROTATION ABOUT THE LONGITUDINAL AXIS OF THE NECK PEG. THE FRACTURE SURFACES OF THE LATERAL PEG HAD A MOTTLED APPEARANCE (SEE ATTACHED PHOTO), WITH NO INDICATIONS OF FATIGUE FRACTURE, SUCH AS ELONGATED RIDGES OR STRIATIONS. BURNISHING OF THE NECK PEG WHERE THE PEG ENGAGED THE STEM WAS CONSISTENT WITH ROTATION OF THE NECK ON THE STEM. THESE FINDINGS SUGGEST THAT FAILURE OCCURRED DUE TO FAILURE OF THE ALIGNMENT PIN AND/OR ENGAGEMENT HOLES, FOLLOWED BY ROTATION OF THE NECK ON TOP OF THE STEM WITH SUBSEQUENT ABRASION OF THE STEM AND NECK SURFACES AND FRACTURE OF THE LATERAL PEG AS DESCRIBED. DIMENSIONAL INSPECTION OF THE MODULAR STEM AND NECK INTERFACES WERE PRECLUDED BY ABRASIVE WEAR SECONDARY TO FAILURE OF THE ALIGNMENT PIN AND MODULAR NECK. REVIEW OF THE INSPECTION RECORDS FOR THE SPECIFIC STEM AND NECK LOTS INDICATES THAT THE DIMENSIONS OF THE MODULAR NECK PEG AND MATING HOLE IN THE STEM WERE WITHIN SPECIFICATION. THE CERTIFICATE OF COMPLIANCE AND CHEMICAL COMPOSITION FOR THE COBALT CHROME ALIGNMENT PIN INDICATES CONFORMANCE TO ANOTHER DEVICE, INCLUDING YIELD STRENGTH (143 KSI), TENSILE STRENGTH (197 KSI), AND ELONGATION (35%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP STEM POROUS FEMORAL STEM LPH OMNI LIFE SCIENCE INC. 5X13MM STEM 501

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention