BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFLEX M-HA HIP STEM

    MDR report key: 4943947 · Received July 27, 2015

    Report

    Report Number
    0002249697-2015-02485
    Event Type
    Injury
    Date Received
    July 27, 2015
    Date of Event
    July 6, 2015
    Report Date
    March 24, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    K920193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES LISTED IN THIS REPORT: CAT. NO.: UNKNOWN; UNKNOWN FEMORAL HEAD, LOT CODE: UNKNOWN. CAT. NO.: 625-0T-36H; TRIDENT ALUMINA INSERT; LOT CODE: U5859802 . AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S PAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN AND REVISION INVOLVING AN OMNIFLEX HIP STEM WAS REPORTED. THE EVENT OF REVISION WAS CONFIRMED HOWEVER PAIN WAS NOT. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION SHOWED LOCALIZED DAMAGE LIKELY DUE TO STEM IMPINGEMENT. NO FURTHER INSPECTIONS WERE PERFORMED. A MATERIAL ANALYSIS HAS BEEN PERFORMED. THE REPORT CONCLUDED: "THE STEM WAS RETURNED WITH THE DISTAL TIP COMPONENT ATTACHED. FOR THE PURPOSES OF THIS ANALYSIS, THE STEM IS CONSIDERED FOR THE RIGHT HIP. EXPLANTATION DAMAGE WAS OBSERVED AT MULTIPLE SITES OF THE STEM TRUNNION AND THE RESULTING SURFACE CONDITION COULD NOT PROVIDE ANY NEW INFORMATION IN CONNECTION TO THE REPORTED EVENT. THE REMAINING SURFACES OF THE HIP STEM DID NOT HAVE ANY REMARKABLE SURFACE INDICATIONS OF NOTE. WEAR SCARS WERE OBSERVED ON THE ARTICULATING SURFACE OF THE HEAD AND THE INSERT. THE WEAR SCARS ON THE INSERT ARE LIKELY TO HAVE OCCURRED BY EDGE-LOADING. THE FEMALE HEAD TAPER EXHIBITED A CONSISTENT CIRCUMFERENTIAL METALLIC BAND PATTERN, AN INDICATION THAT THE TRUNNION WAS LIKELY PROPERLY SEATED IN THE TAPER. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EXAMINED." MEDICAL RECORDS RECEIVED AND EVALUATION: REVIEW OF MEDICAL RECORDS BY A CONSULTING CLINICIAN INDICATED THERE IS INSUFFICIENT INFORMATION AVAILABLE FOR A MEDICAL REVIEW. ADDITIONAL INFORMATION SUCH AS OPERATIVE REPORTS, EXAMINATION OF EXPLANTED DEVICES, AND CLARIFICATION ON WHETHER EVENT REGARDS LEFT OR RIGHT HIP. DEVICE HISTORY REVIEW: THERE HAVE BEEN NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO REPORTED EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EVENT OF REVISION WAS CONFIRMED WITH THE RETURN OF THE EXPLANTED DEVICES. PAIN AND STIFFNESS COULD NOT BE CONFIRMED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT PRESENTED IN SURGEON'S OFFICE WITH SEVERE LEG PAIN AND STIFFNESS PREVENTING THEM FROM PERFORMING ADLS AND IT WAS DETERMINED THAT A REVISION WAS NECESSARY FROM RADIOGRAPHIC IMAGES. SURGEON REMOVED PRIMARY HIP STEM, FEMORAL HEAD, AND ACETABULAR LINER THEN ATTEMPTED TO REPLACE WITH MONOLITHIC HIP STEM BEFORE FINALLY DECIDING THAT THE RESTORATION MODULAR BROACH PROXIMAL BODY WITH A CYLINDRICAL PLASMA HA DISTAL STEM, V40 LFIT HEAD, AND X3 LINER WAS THE BEST COURSE OF ACTION.

    Description of Event or Problem · 1

    PATIENT PRESENTED IN SURGEON'S OFFICE WITH SEVERE LEG PAIN AND STIFFNESS PREVENTING THEM FROM PERFORMING ADLS AND IT WAS DETERMINED THAT A REVISION WAS NECESSARY FROM RADIOGRAPHIC IMAGES. SURGEON REMOVED PRIMARY HIP STEM, FEMORAL HEAD, AND ACETABULAR LINER THEN ATTEMPTED TO REPLACE WITH MONOLITHIC HIP STEM BEFORE FINALLY DECIDING THAT THE RESTORATION MODULAR BROACH PROXIMAL BODY WITH A CYLINDRICAL PLASMA HA DISTAL STEM, V40 LFIT HEAD, AND X3 LINER WAS THE BEST COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486816 OMNIFLEX M-HA HIP STEM IMPLANT KWL STRYKER ORTHOPAEDICS-MAHWAH 17645302

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention