BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #4

    MDR report key: 8860622 · Received August 5, 2019

    Report

    Report Number
    0002249697-2019-02747
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    July 7, 2019
    Report Date
    November 12, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    04546540510693
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING DISASSOCIATION AND FRETTING INVOLVING A ACCOLADE STEM WAS REPORTED. THE EVENT WAS CONFIRMED BY EVALUATION OF THE RETURNED DEVICE AND MEDICAL REVIEW. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: THE ACCOLADE STEM WITH COMPETITOR'S CUP AND HEAD WERE RETURNED. THE TRUNNION OF THE STEM WAS PENCILED TO A POINTED TIP. DAMAGE CONSISTENT WITH LOSS OF TAPER LOCK AND IMPINGEMENT WAS OBSERVED ON THE STEM NECK AND MAIN BODY. BIOLOGICAL MATERIAL WAS ALSO OBSERVED ON THE COATED REGION OF THE STEM. DAMAGE CONSISTENT WITH LOSS OF TAPER LOCK AND IMPINGEMENT WAS OBSERVED ON THE STEM NECK AND MAIN BODY. XRF ON THE STEM WAS SHOWED THAT IT WAS CONSISTENT WITH AN ASTM F1813 ALLOY. THE STEM WAS REPORTED TO HAVE BEEN USED WITH AN ADEPT HEAD. BASED ON THE GIVEN INFORMATION, NO IDENTIFIABLE MATERIALS OR MANUFACTURING DISCREPANCIES WERE OBSERVED ON THE SURFACES EXAMINED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL INFORMATION BY A CLINICAL CONSULTANT INDICATED: "CATASTROPHIC FAILURE OF THE LEFT HIP IS CONFIRMED WITH DISASSOCIATION BETWEEN FEMORAL HEAD AND STEM TRUNNION THAT IS RESTING AGAINST THE RIM OF THE ADEPT CUP (COMPETITOR DEVICE). SEVERE METALLOSIS IN AND AROUND THE JOINT SPACE WITH SEVERE OSTEOLYSIS EVIDENT IN THE SUPERIOR ACETABULAR BONE AREA, CUP STABILITY IS QUESTIONABLE." DISASSOCIATION BETWEEN ADEPT FEMORAL HEAD AND ACCOLADE TMZF STEM TRUNNION OCCURRED SOME 10-YEARS POST ARTHROPLASTY WITH ADEPT METAL-ON-METAL BEARING REQUIRING REVISION SURGERY. NO FINAL AND EXACT CONCLUSION POSSIBLE ABOUT FAILURE MODE DUE TO LACK OF RELEVANT INFORMATION ALTHOUGH SOME RISK FACTORS COULD BE IDENTIFIED INCLUDING HIGHER BEARING FRICTION WITH USE OF LARGE MOM FEMORAL HEADS AS WELL AS HIGH PATIENT ACTIVITY. USE OF LARGE 50-MM FEMORAL HEAD IN A METAL-ON-METAL ARTICULATION COULD CONTRIBUTE TO THE EVENT. OTHERWISE NO RECOGNISABLE PROCEDURE-RELATED FACTORS, ADEQUATE COMPONENT POSITIONS. HIGH PATIENT ACTIVITY RELATIVE AND SECONDARY FACTOR CONTRIBUTING TO THE EVENT. PRODUCT HISTORY REVIEW: A REVIEW OF THE DEVICE MANUFACTURING RECORDS INDICATE THAT ALL DEVICES ACCEPTED INTO FINAL STOCK WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: EXAMINATION OF THE RETURNED DEVICE DETERMINED THAT DAMAGE CONSISTENT WITH LOSS OF TAPER LOCK AND IMPINGEMENT WAS OBSERVED ON THE STEM NECK AND MAIN BODY. BIOLOGICAL MATERIAL WAS ALSO OBSERVED ON THE COATED REGION OF THE STEM. XRF ON THE STEM WAS SHOWED THAT IT WAS CONSISTENT WITH AN ASTM F1813 ALLOY. THE STEM WAS REPORTED TO HAVE BEEN USED WITH AN ADEPT HEAD. BASED ON THE GIVEN INFORMATION, NO IDENTIFIABLE MATERIALS OR MANUFACTURING DISCREPANCIES WERE OBSERVED ON THE SURFACES EXAMINED. THE MEDICAL REVIEW REVEALED THAT NO FINAL AND EXACT CONCLUSION POSSIBLE ABOUT FAILURE MODE DUE TO LACK OF RELEVANT INFORMATION ALTHOUGH SOME RISK FACTORS COULD BE IDENTIFIED INCLUDING HIGHER BEARING FRICTION WITH USE OF LARGE MOM FEMORAL HEADS AS WELL AS HIGH PATIENT ACTIVITY. USE OF LARGE 50-MM FEMORAL HEAD IN A METAL- ON-METAL ARTICULATION COULD CONTRIBUTE TO THE EVENT. OTHERWISE NO RECOGNISABLE PROCEDURE- RELATED FACTORS, ADEQUATE COMPONENT POSITIONS. HIGH PATIENT ACTIVITY RELATIVE AND SECONDARY FACTOR CONTRIBUTING TO THE EVENT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    ON (B)(6) 2009 FIRST LEFT THA. PATIENT ACTIVITY WAS HIGH AND ENGAGED IN AGRICULTURE. AT THE SAME TIME, THIS IMPLANTING WAS GOOD AND CARRIED OUT AN OPERATION. VISITED TO OUR HOSPITAL WITH A DISCOMFORT IN THE LEFT HIP JOINT AND CONFIRMED A DEFECT IN THE THA IMPLANT. THEN WHEN HE PATIENT STOOD UP FROM THE CHAIR, THE PATIENT FELT LIKE LEFT HIP CAME OFF. THE PATIENT IMMEDIATELY VISITED TO THE HOSPITAL AND WAS SCHEDULED FOR HOSPITALIZATION AND SURGERY. DURING THE FOLLOW-UP, THE METAL HEAD/STEM NECK TRUNNION OVERLAPPED, THE PATIENT IS ALSO DOING THE SAME THA TO THE RIGHT. A REVISION HAS BEEN MADE IN SEPTEMBER 2016 WITH THE SAME COMPLAINT. (THE SAFETY MANAGEMENT REPORT HAS BEEN SUBMITTED BY THE PERSON IN CHARGE BEFORE) DURING THE FOLLOW-UP, THE METAL HEAD / STEM NECK TRUNNION OVERLAPPED AND COULD NOT BE CONFIRMED IN ADVANCE BY PHOTOGRAPHY. IMPLANTED PRODUCT: 6021-0435 ACCOLADE TMZF 127 DEGREE 4TH, 172581 ADEPT CUP OUTER DIAMETER 58 MM INNER DIAMETER 50 MM, 179-350 ADEPTV40 MODULAR HEAD DIAMETER 50 MM-0 MM. UPDATE ON 24-SEP-2019 BY QS: BASED ON THE PROVIDED MEDICAL REVIEW, "CATASTROPHIC FAILURE OF THE LEFT HIP IS CONFIRMED WITH DISASSOCIATION BETWEEN FEMORAL HEAD AND STEM TRUNNION THAT IS RESTING AGAINST THE RIM OF THE ADEPT CUP. SEVERE METALLOSIS IN AND AROUND THE JOINT SPACE WITH SEVERE OSTEOLYSIS EVIDENT IN THE SUPERIOR ACETABULAR BONE AREA."

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2009 FIRST LEFT THA . PATIENT ACTIVITY WAS HIGH AND ENGAGED IN AGRICULTURE. AT THE SAME TIME, THIS IMPLANTING WAS GOOD AND CARRIED OUT AN OPERATION. VISITED TO OUR HOSPITAL WITH A DISCOMFORT IN THE LEFT HIP JOINT, AND CONFIRMED A DEFECT IN THE THA IMPLANT. THEN WHEN HE PATIENT STOOD UP FROM THE CHAIR, THE PATIENT FELT LIKE LEFT HIP CAME OFF. THE PATIENT IMMEDIATELY VISITED TO THE HOSPITAL AND WAS SCHEDULED FOR HOSPITALIZATION AND SURGERY. DURING THE FOLLOW-UP, THE METAL HEAD / STEM NECK TRUNNION OVERLAPPED, THE PATIENT IS ALSO DOING THE SAME THA TO THE RIGHT. A REVISION HAS BEEN MADE IN SEPTEMBER 2016 WITH THE SAME COMPLAINT. (THE SAFETY MANAGEMENT REPORT HAS BEEN SUBMITTED BY THE PERSON IN CHARGE BEFORE) DURING THE FOLLOW-UP, THE METAL HEAD / STEM NECK TRUNNION OVERLAPPED AND COULD NOT BE CONFIRMED IN ADVANCE BY PHOTOGRAPHY. IMPLANTED PRODUCT: 6021-0435, ACCOLADE TMZF 127 DEGREE 4TH, 172581, ADEPT CUP OUTER DIAMETER 58 MM INNER DIAMETER 50 MM, 179-350, ADEPTV40 MODULAR HEAD DIAMETER 50 MM-0 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654694 ACCOLADE PLUS TMZF HIP STEM #4 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 29779303 04546540510693

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R