BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5

    MDR report key: 3290028 · Received August 15, 2013

    Report

    Report Number
    0002249697-2013-02710
    Event Type
    Injury
    Date Received
    August 15, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 23, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN UNKNOWN MITCH CUP MANUFACTURED BY DEPUY WAS ALSO LISTED IN THIS REPORT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A REACTION INVOLVING AN ACCOLADE (127 DEG) SIZE 4.5 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: A MATERIAL ANALYSIS NOTED A LACK OF ONGROWTH ON THE STEM. A MATERIAL ANALYSIS HAS BEEN PERFORMED. THE REPORT CONCLUDED: ¿MINOR AMOUNTS OF BONEY ON-GROWTH WERE PRESENT [ON THE STEM]¿MINOR AMOUNTS OF BONEY ON-GROWTH WERE OBSERVED ON THE COMPONENTS EXAMINED. A WEAR PATTERN WAS OBSERVED ON THE ARTICULATING SURFACES OF BOTH THE FEMORAL HEAD AND MITCH CUP. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SAMPLES EXAMINED.¿ MEDICAL RECORDS RECEIVED AND EVALUATION: THE CLINICAL CONSULTANT COULD NOT CONFIRM THE EVENT BASED ON THE PROVIDED MEDICAL RECORDS. A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED: ¿BASED UPON THE INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO CONFIRM THE DIAGNOSIS OF ALVAL, ALTR, OR PSEUDOTUMOR AS THE CAUSE OF THIS CLINICAL SITUATION.¿ DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW CONFIRMED NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. FURTHER INFORMATION SUCH AS PATHOLOGY REPORTS, SERIAL COBALT AND CHROMIUM LEVELS, AND ADDITIONAL LAB RESULTS IS NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE. 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.

    Description of Event or Problem · 1

    REVISION TOTAL HIP REPLACEMENT. PRIMARY WAS MITCH/ACCOLADE. ACCORDING TO THE OPERATIVE REPORT, THERE WAS A MARKED SOFT TISSUE REACTION WITH MARKED EFFUSION. THE STEM WAS COMPLETELY LOOSE WITH NO IN-GROWTH. THE CUP WAS RETROVERTED SLIGHTLY, NOT IN-GROWN BUT NOT LOOSE.

    Description of Event or Problem · 1

    REVISION TOTAL HIP REPLACEMENT. PRIMARY WAS MITCH/ACCOLADE. ACCORDING TO THE OPERATIVE REPORT, THERE WAS A MARKED SOFT TISSUE REACTION WITH MARKED EFFUSION. THE STEM WAS COMPLETELY LOOSE WITH NO IN-GROWTH. THE CUP WAS RETROVERTED SLIGHTLY, NOT IN-GROWN BUT NOT LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395061 ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 19431232

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R