BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4140304 · Received October 3, 2014

    Report

    Report Number
    0002249697-2014-03735
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 25, 2013
    Report Date
    September 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A REVISION INVOLVING AN UNKNOWN METAL HEAD WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: A REVIEW OF THE IMAGE OF THE FEMORAL HEAD ON THE ACCOLADE STEM INDICATES THAT A DEGREE OF MOTION BETWEEN THE HEAD AND THE TRUNNION MUST HAVE BEEN PRESENT. NO DAMAGE TO THE FEMORAL HEAD WAS IDENTIFIED FROM THE IMAGE AVAILABLE. DEVICE RETURN IS HOWEVER REQUIRED TO COMPLETE A MORE IN DEPTH VISUAL ANALYSIS ALONG WITH A MATERIAL ANALYSIS OF THE FEMORAL HEAD. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS PERFORMED AND CONCLUDED: ISSUE WITH REVISION OF ACCOLADE TMZF STEM DUE TO TAPER DISSOCIATION WITH SEVERE SUBSTANCE LOSS SOME 8-YEARS POST PRIMARY ARTHROPLASTY IN A MALE PATIENT OF (B)(6) WITH UNKNOWN WEIGHT, HEIGHT OR ACTIVITY LEVEL. COBALT AND CHROME IN BLOOD WERE SLIGHTLY ELEVATED WITH COBALT 2,5 UG/L (REF 1,8) AND CHROME 2,1 UG/L (REF 1,8). X-RAYS SHOW THE TRIDENT CUP WAS PLACED RATHER DEEP IN ACETABULAR CAVITY WITH HARDLY ANY ANTEVERSION. STEM AND CUP HAD OTHERWISE STABLE FIXATION. AT REVISION METALLOSIS WAS CONFIRMED AND THE ACCOLADE STEM WAS REPLACED WITH RESTORATION MODULAR SYSTEM DEVICE. TROCHANTERIC ACCESS OSTEOTOMY STABILIZED WITH A DALL-MILES CABLE. NO IMPLANTS WERE RETURNED FOR INVESTIGATION. LACK OF CUP ANTEVERSION PLUS A MEDIALIZED POSITION CONTRIBUTE TO IMPLANT OR BONY IMPINGEMENT THEREBY CERTAINLY CONTRIBUTING TO OVERLOAD IN THE BEARING RESULTING IN A ¿TOGGLE¿ TYPE OF EFFECT BETWEEN FEMORAL HEAD AND TAPER WITH CONSEQUENT TAPER CORROSION DEVELOPMENT WITH SUBSTANCE LOSS UPON FURTHER PROGRESSION. SERIAL X-RAYS OF BETTER QUALITY AND EXPLANT MATERIALS ANALYSIS MIGHT PROVIDE ADDITIONAL CLUES TO THE FAILURE MECHANISM PRESENT IN THIS CASE. ROOT CAUSE OF FAILURE IS THUS MOST PROBABLY AN ADVERSE MIX OF PATIENT-RELATED FACTORS (OVERWEIGHT? ONLY SUSPECTED) AND PROCEDURE-RELATED FACTORS WHERE CUP MALPOSITION IS CLEARLY ONE IMPORTANT PROCEDURE-RELATED FACTOR TO CONTRIBUTE TO AN OVERLOAD CONDITION IN THE ARTHROPLASTY ARTICULATION ALTHOUGH POSSIBLY NOT THE ONLY ONE FACTOR INVOLVED. AS SUCH, THE ROOT FAILURE CAUSE CANNOT BE RECONSTRUCTED WITH MORE CERTAINTY DUE TO THE LIMITED INFORMATION AVAILABLE ALTHOUGH PROCEDURE-RELATED FACTORS ARE PRESENT WITHOUT ANY DOUBT. CONCLUSIONS: A MEDICAL REVIEW WAS PERFORMED, THE ROOT CAUSE OF FAILURE COULD NOT BE CONFIRMED BASED ON THE INFORMATION AVAILABLE HOWEVER PROCEDURAL FACTORS WERE EVIDENT DUE TO THE INADEQUATE POSITIONING OF THE TRIDENT SHELL. FURTHER INFORMATION SUCH AS RETURN OF THE DEVICE, OPERATIVE REPORTS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS DESCRIBED AS AN UNKNOWN 36MM METAL HEAD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF THE ACCOLADE STEM. THE REP WAS UNAWARE OF THE REASON FOR REVISION AS HE WAS ALERTED TO THE CASE THE SAME DAY AND GIVEN MINIMAL INFORMATION. UPDATE AS PER LITERATURE ARTICLE: IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED FOR A FAILURE AT THE MODULAR HEAD NECK JUNCTION DUE TO TRUNNION WEAR. ON THE DAY OF ADMISSION, PATIENT HEARD A CRACK WHEN HE STOOD UP AND FELT SEVERE LATERAL HIP PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF THE ACCOLADE STEM. THE REP WAS UNAWARE OF THE REASON FOR REVISION AS HE WAS ALERTED TO THE CASE THE SAME DAY AND GIVEN MINIMAL INFORMATION. UPDATE AS PER LITERATURE ARTICLE: IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED FOR A FAILURE AT THE MODULAR HEAD NECK JUNCTION DUE TO TRUNNION WEAR. ON THE DAY OF ADMISSION, PATIENT HEARD A CRACK WHEN HE STOOD UP AND FELT SEVERE LATERAL HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617906 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R