BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3533204 · Received December 23, 2013

    Report

    Report Number
    0002249697-2013-04156
    Event Type
    Injury
    Date Received
    December 23, 2013
    Date of Event
    December 3, 2013
    Report Date
    December 3, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING INCREASED CR LEVEL INVOLVING AN UNKNOWN ACCOLADE TMZF STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: THE ACCOLADE STEM WAS NOT RETURNED. A MATERIAL ANALYSIS HAS BEEN PERFORMED ON THE ASSOCIATED MITCH COMPONENTS. THE REPORT CONCLUDED: ¿THE MATERIAL FOUND ON THE MACHINED TAPERED SURFACE OF THE HEAD CONTAINED TI-CR-MO-CO, CA AND P, CONSISTENT WITH BIOLOGICAL MATERIAL, MATERIAL TRANSFER FROM THE FEMORAL STEM AND CORROSION PRODUCTS. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE COMPONENTS EXAMINED.¿ MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED MEDICAL INFORMATION WAS REVIEWED BY A CONSULTING CLINICIAN WHO CONCLUDED: ¿THE ACCOLADE STEM IN THIS CASE HAS NO DEVICE-RELATED FACTORS INVOLVED TO PLAY A ROLE IN THE OVERALL FAILURE MODE DUE TO PAIN AND ELEVATED CHROME IONS. NEITHER WOULD PATIENT-RELATED FACTORS PLAY ANY ROLE.¿ CONCLUSIONS: BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT WAS NOT RELATED TO THE ACCOLADE STEM. X-RAYS CONFIRMED ADEQUATE SIZE AND POSITION OF THE STEM WITH STABLE FIXATION IN THE BONE AND NO APPARENT ADVERSE BONY PATHOLOGY. EVIDENCE OF WEAR WAS NOTED ON THE MITCH COMPONENTS. THIS EVENT IS UNDER THE SCOPE OF RA 2012-080, INITIATED IN RESPONSE TO THE FIELD SAFETY NOTICE FOR MITCH TRH CUP /HEAD WHEN IMPLANTED WITH THE UNCEMENTED ACCOLADE STEM. A REVIEW OF POST-MARKET SURVEILLANCE DATA SUGGESTED A HIGHER THAN EXPECTED REVISION RATE FOR THIS DEVICE COMBINATION. THE FIELD SAFETY NOTICE ADVISES AGAINST THIS COMBINATION AND RECOMMENDS PATIENTS BE FOLLOWED ACCORDING TO LOCAL GUIDANCE/STANDARD OF CARE FOR PATIENTS RECEIVING METAL ON METAL ARTICULATIONS.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # MMH-9988-5044, LOT # FM060031, DESCRIPTION: MITCH TRH RES HD SZ44, MANUFACTURER: DEPUY; CAT # MAC-9988-4450, LOT # FM091404, DESCRIPTION: STD MITCH TRH CP SZ 44/50, MANUFACTURER: DEPUY. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. DEVICE REMAINED IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY OF HER LEFT HIP DUE TO PAIN AND INCREASED CHROMIUM LEVELS. SURGEON REPLACED MITCH WITH A DEPUY CUP AND LEFT THE ACCOLADE TMZF IN-SITU.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY OF HER LEFT HIP DUE TO PAIN AND INCREASED CHROMIUM LEVELS. SURGEON REPLACED MITCH WITH A DEPUY CUP AND LEFT THE ACCOLADE TMZF IN-SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671648 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| O