BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP STEM

    MDR report key: 1081724 · Received July 25, 2008

    Report

    Report Number
    1226188-2008-00022
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 19, 2008
    Report Date
    July 23, 2008
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    KWY
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL IMPLANT RETURNED: NECK, LONG 50MM CAT# 200610 LOT# 253 MFG. DATE 4/16/02 EXP. DATE 4/30/07. RESULTS OF INVESTIGATION: THERE WERE TWO PIECES AVAILABLE FOR EXAMINATION: THE TITANIUM ALLOY FEMORAL STEM AND THE TITANIUM ALLOY MODULAR NECK. THE PROXIMAL END OF THE FEMORAL STEM SHOWED SOME RETAINED BONE AT THE INGROWTH SURFACE, AND TWO SMALL PATCHES OF MISSING POROUS COATING (AT THE DISTAL EXTENT OF COATING) AND SEVERAL MINOR SCRATCHES SECONDARY TO SURGICAL REMOVAL OF THE STEM. THE MACHINING MARKS WERE STILL EVIDENT ON THE TOP SURFACE OF THE STEM AND THE MATING UNDERSURFACE OF THE NECK (SEE ATTACHED PHOTOS). THE COBALT CHROME ALIGNMENT PIN WAS IN PLACE AND FULLY INTACT. THE MATING UNDERSURFACE OF THE NECK WAS FULLY INTACT, WITH VISUAL EVIDENCE OF MINIMAL SURFACE ABRASION OR FRETTING (ONLY). THE ALIGNMENT PIN HOLES WERE INTACT AND DID NOT APPEAR TO BE DEFORMED. TWO BANDS OF MINOR SURFACE ABRASION WERE VISIBLE ON THE LATERAL PEG OF THE NECK CORRESPONDING TO THE AREAS OF DIAMETRAL INTERFERENCE BETWEEN THE PEG AND THE LATERAL HOLE IN THE FEMORAL STEM. THERE WAS NO VISUAL EVIDENCE OF SIGNIFICANT MOTION BETWEEN THE FEMORAL NECK AND THE FEMORAL STEM. THERE WERE SEVERAL MINOR "NICKS" ON THE NECK TRUNNION, DISTAL TO THE TAPERED HEAD INTERFACE, THAT WERE LIKELY CAUSED BY THE HEAD REMOVAL TOOL.

    Description of Event or Problem · 1

    PT HAD A PREVIOUS LEFT TOTAL HIP ARTHROPLASTY IN 2003. PT DEVELOPED CHRONIC DISLOCATION AFTER A FALL FOUR YRS AFTER HIP SURGERY. REVISION WAS PERFORMED TO CORRECT CHRONIC DISLOCATION. IT WAS REPORTED THAT THE PT IS DOING WELL POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP STEM POROUS FEMORAL STEM KWY OMNI LIFE SCIENCE, INC. SZ 3 X 10MM 337

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R