BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5

    MDR report key: 3181288 · Received June 21, 2013

    Report

    Report Number
    0002249697-2013-02006
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    September 3, 2012
    Report Date
    May 29, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALLERGY/REACTION INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. VISUAL INSPECTION REVEALED SPARSE BONY ON-GROWTH WAS OBSERVED ON THE COATED SURFACE OF THE STEM. BLACKENING WAS OBSERVED ON THE TRUNNION. A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: NO CLINICAL OR PAST MEDICAL HISTORY, NO X-RAYS, NO PATIENT DEMOGRAPHICS, AND NO RESULTS OF EXAMINATIONS OF SPECIMENS SENT FROM THE (B)(6) 2013 REVISION SURGERY ARE AVAILABLE FOR REVIEW. THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS AS BEING RESPONSIBLE FOR THIS CLINICAL SITUATION AND THERE IS NO PATHOLOGIC CONFIRMATION OF ¿ADVERSE REACTION TO METAL DEBRIS¿ AS NOTED IN THE OPERATIVE REPORT OF (B)(6) 2013. A MATERIAL ANALYSIS HAS BEEN PERFORMED. THE REPORT CONCLUDED: THE TRUNNION OF THE NECK AND THE FEMALE TAPER SIDE OF THE HEAD WERE EXHIBITING CORROSION. THE BASE ALLOY OF THE STEM WAS FOUND TO BE A TI-MO-ZR-FE ALLOY CONSISTENT WITH AN ASTM F 1813 ALLOY. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAS BEEN 1 OTHER EVENT FOR THE LOT REFERENCED. THE EVENT WAS A DUPLICATE OF THIS EVENT AND WAS CANCELLED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS PATIENT DETAILS AND MEDICAL HISTORY AND RESULTS OF EXAMINATIONS OF SPECIMENS SENT FROM THE (B)(6) 2013 REVISION SURGERY ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT:CAT # 6260-9-036, LOT # MHAJP6, DESCRIPTION: V40 COCR LFIT HEAD 36MM/-5.CAT # 500-11-60G, LOT # 26817301, DESCRIPTION: TRIDENT HEMISPHERICAL SOLID BACK SHELL.CAT # 623-10-36G, LOT # 27260401, DESCRIPTION: TRIDENT 10° X3 INSERT 36MM ID.IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY ARE STILL IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4): DEVICE IMPLANTED.

    Description of Event or Problem · 1

    THE CONSULTANT REPORTED TO THE (B)(4) THAT A PATIENT HAS HAD AN ARMD (ADVERSE REACTION TO A MEDICAL DEVICE). THE CONSULTANT REPORTED THAT THE PATIENT HAD A PRE-EXISTING MOM SYNERGY BIRMINGHAM HIP IMPLANTS ON THE RIGHT SIDE WHICH WERE REVISED ON THE (B)(6) 2010 FOR AN ARMD. THE EVENT DATE IS APPROX AS THE REPORTING CONSULTANT REPORTED THE REVISION DATE AS THE (B)(6) 2013.

    Description of Event or Problem · 1

    THE CONSULTANT REPORTED TO THE (B)(4) THAT A PATIENT HAS HAD AN ARMD (ADVERSE REACTION TO A MEDICAL DEVICE). THE CONSULTANT REPORTED THAT THE PATIENT HAD HAD A PRE-EXISTING MOM SYNERGY BIRMINGHAM HIP IMPLANTS ON THE RIGHT SIDE WHICH WERE REVISED ON THE 11.11.10 FOR AN ARMD.THE EVENT DATE IS APPROX AS THE REPORTING CONSULTANT REPORTED THE REVISION DATE AS THE (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282493 ACCOLADE (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 14575401

    Patients

    Seq Age Sex Outcome Treatment
    1 Other