BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6547915 · Received May 5, 2017

    Report

    Report Number
    0002249697-2017-01449
    Event Type
    Injury
    Date Received
    May 5, 2017
    Date of Event
    March 25, 2017
    Report Date
    July 14, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED CATALOG NUMBER AND LOT CODE OF UNKNOWN 54MM MITCH CUP PREVIOUSLY LISTED IN THIS REPORT: CAT # MAC-9988-4854LOT # FM 60674-014, DESCRIPTION: STD MITCH TRH CP SZ 48/54, MANUFACTURER: DEPUY. AN EVENT REGARDING PAIN, CRACK/FRATURE & ALTR INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS CONFIRMED. A MEDICAL REVIEW ALSO CONFIRMED CORROSION. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: A VISUAL INSPECTION WAS PERFORMED BY A MATERIAL ANALYSIS ENGINEER WHICH NOTED: THE PARTS WERE EXAMINED WITH THE AID OF A STEREO MICROSCOPE AT MAGNIFICATIONS UP TO 50X. DAMAGE CONSISTENT WITH THE EXPLANTATION PROCESS WAS OBSERVED ON THE STEM IN ADDITION TO BIOLOGICAL FIXATION. ALL SURFACES OF THE NECK EXHIBITED DAMAGE, CONSISTENT WITH WEAR MECHANISMS DUE TO THE HEAD TAPER AND STEM TRUNNION LOSING THEIR TAPER LOCK. BASED ON MACROSCOPIC FEATURES, THE APPROXIMATE DIRECTION OF FRACTURE PROPAGATION IS SEEN. DAMAGE CONSISTENT WITH A WEAR MECHANISM LIKELY AIDED IN THE NECK FRACTURE. DAMAGE WAS OBSERVED ON THE HEAD CONSISTENT WITH CONTACT AGAINST THE STEM TRUNNION. THE NECK WAS ANALYZED UNDER A SCANNING ELECTRON MICROSCOPE (SEM) FOR FURTHER EVALUATION. -MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS, X-RAYS, PHOTOGRAPHS AND MAR BY A CLINCIAL CONSULTANT NOTED THE FOLLOWING: PROCEDURE-RELATED FACTORS: - CUP MALPOSITION IN LOW INCLINATION AND MEDIALIZED POSITION. - PRESENCE OF A RELATIVELY HIGH FRICTION MOM BEARING WITH BIG HEAD SIZE. - HETEROTOPIC OSSIFICATIONS IN AND AROUND THE JOINT SPACE. PATIENT-RELATED FACTORS - HETEROTOPIC OSSIFICATIONS IN AND AROUND THE JOINT SPACE. DEVICE-RELATED FACTORS: - NONE AS ALSO SUPPORTED BY MAR FINDINGS. DIAGNOSIS: - CUP MALPOSITION IN LOW INCLINATION AND MEDIALIZED POSITION PLUS USE OF A RELATIVELY HIGH FRICTION MOM BEARING AND PRESENCE OF HETEROTOPIC OSSIFICATIONS HAVE CAUSED AN OVERLOAD CONDITION IN THE ARTHROPLASTY CONTRIBUTING TO TAPER CORROSION WITH PROGRESSIVE SUBSTANCE LOSS AND FINALLY A STEM NECK FRACTURE WITH SECONDARY METALLOSIS IN THE TISSUES REQUIRING REVISION. -DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENT FOR THIS LOT. CONCLUSIONS: A REVIEW OF THE PROVIDED MEDICAL RECORDS, X-RAYS, PHOTOGRAPHS AND MAR BY A CLINCIAL CONSULTANT CONCLUDED CUP MALPOSITION IN LOW INCLINATION AND MEDIALIZED POSITION PLUS USE OF A RELATIVELY HIGH FRICTION MOM BEARING AND PRESENCE OF HETEROTOPIC OSSIFICATIONS HAVE CAUSED AN OVERLOAD CONDITION IN THE ARTHROPLASTY CONTRIBUTING TO TAPER CORROSION WITH PROGRESSIVE SUBSTANCE LOSS AND FINALLY A STEM NECK FRACTURE WITH SECONDARY METALLOSIS IN THE TISSUES REQUIRING REVISION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # UNKNOWN, LOT # UNKNOWN, DESCRIPTION: UNKNOWN 54 MM MITCH CUP, MANUFACTURER: DEPUY. CAT # UNKNOWN, LOT # UNKNOWN, DESCRIPTION: UNKNOWN MITCH 48 MM INNER HEAD, 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT HAD HIP REVISION PERFORMED DUE TO PERIODS OF PAIN. UPON X-RAY, APPEARANCE OF HEAD AND TRUNION NOTICED. ON (B)(6) 2017 PATIENT HAD ALL ITEMS IN SITU REMOVED AND REVISION SURGERY PERFORMED. METALOSIS NOTED UPON INCISION, TRUNION HAD BROKEN IN SITU - NOTICED AT TIME OF REVISION. THE STEM REMOVED ON (B)(6) 2017 WAS AN ACCOLADE TMZF SIZE 4.5, UNSURE IF 127 OR 132 DEGREE NECK ANGLE. CUP WAS 54MM MITCH CUP WITH 48MM INNER HEAD.

    Description of Event or Problem · 1

    PATIENT HAD HIP REVISION PERFORMED DUE TO PERIODS OF PAIN. UPON X-RAY, APPEARANCE OF HEAD AND TRUNNION NOTICED. ON (B)(6) 2017 PATIENT HAD ALL ITEMS IN SITU REMOVED AND REVISION SURGERY PERFORMED. METALLOSIS NOTED UPON INCISION, TRUNNION HAD BROKEN IN SITU - NOTICED AT TIME OF REVISION. THE STEM REMOVED ON (B)(6) 2017 WAS AN ACCOLADE TMZF SIZE 4.5, UNSURE IF 127 OR 132 DEGREE NECK ANGLE. CUP WAS 54 MM MITCH CUP WITH 48 MM INNER HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330443 ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 22252002

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R