BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7639258 · Received June 26, 2018

    Report

    Report Number
    0002249697-2018-01968
    Event Type
    Injury
    Date Received
    June 26, 2018
    Date of Event
    May 23, 2018
    Report Date
    November 7, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    04546540510761
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING DISASSOCIATION, CRACK/FRACTURE AND ALTR INVOLVING A ACCOLADE STEM WAS REPORTED. THE DISASSOCIATION AND CRACK/FRACTURE WERE CONFIRMED FOLLOWING MAR AND CLINICIAN REVIEW. ALTR WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS REPORT (MAR), DATED 25 JULY 2018 WHICH INDICATED: [...] THE HIP STEM WAS ASSUMED TO BE A RIGHT HIP IMPLANT. IF SUBSEQUENT INFORMATION INDICATES THE IMPLANT IS FOR THE LEFT HIP, THE ANTERIOR AND POSTERIOR SURFACES ARE REVERSED. THE ANTERIOR, POSTERIOR, SUPERIOR AND INFERIOR SURFACES OF THE ACCOLADE NECK ARE SHOWN. ALL SURFACES OF THE NECK EXHIBITED DAMAGE, CONSISTENT WITH WEAR MECHANISMS DUE TO THE HEAD TAPER AND ACCOLADE STEM TRUNNION LOSING THEIR TAPER LOCK IN ADDITION TO EXPLANTATION DAMAGE. THE TAPER OF THE STEM FRACTURED. THE TRUNNION OF THE STEM WAS NOT RETURNED.[...] MATERIAL ANALYSIS: A MATERIAL ANALYSIS HAS BEEN PERFORMED. THE REPORT CONCLUDED: DAMAGE WAS OBSERVED ON THE ACCOLADE TRUNNION AND V40 HEAD TAPER. THIS DAMAGE WAS CONSISTENT WITH WEAR MECHANISMS DUE TO THE HEAD TAPER AND ACCOLADE STEM TRUNNION LOSING THEIR TAPER LOCK. THE TRUNNION OF THE STEM HAD FRACTURED, WITH THE FRACTURE INITIATING IN FATIGUE AND THE FINAL FRACTURE OCCURRING IN OVERLOAD. A MAJORITY OF THE STEM TRUNNION HAD ALREADY BEEN DESTROYED BY THE LOSS OF TAPER LOCK AND ARTICULATION OF TAPER AND TRUNNION. THE INTERGRANULAR FRACTURE MORPHOLOGIES WERE OBSERVED NEAR THE LOCATION OF FINAL FRACTURE ON THE TRUNNION. EDS SHOWED THE STEM WAS CONSISTENT WITH ASTM F1813 ALLOY.[...] CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED: [...] PATIENT UNDERWENT AN UNCOMPLICATED PRESSFIT THA ON (B)(6) 2008. HE APPARENTLY DID WELL UNTIL (B)(6) 2018 WHEN WHILE WALKING HE HEARD A POP AND FELL TO THE GROUND. HE HAD IMMEDIATE PAIN AND WAS UNABLE TO WEIGHT BEAR. HE WAS TRANSFERRED BY AMBULANCE TO THE EMERGENCY DEPARTMENT WHERE X-RAYS SHOWED A FEMORAL COMPONENT FRACTURE WITH DISPLACED FEMORAL HEAD. THIS THA WAS REVISED ON (B)(6) 2018 DUE TO FRACTURING OF THE NECK OF THE FEMORAL COMPONENT AT THE LEVEL OF THE TRUNNION. THE EXPLANTED STEM HEAD AND ACETABULAR INSERT WERE SENT FOR DETAILED MATERIAL ANALYSIS. ALL SURFACES OF THE NECK OF THE FEMORAL STEM EXHIBITED DAMAGE CONSISTENT WITH WEAR MECHANISMS DUE TO THE HEAD TAPER AND STEM TRUNNION LOSING THEIR TAPER LOCK.[...] DEVICE HISTORY REVIEW: ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSION: A REVIEW BY A CLINICAL CONSULTANT CONCLUDED, "REVIEW OF THESE RECORDS CONFIRMS FRACTURE OF THE FEMORAL STEM OF A THA OCCURRED. MATERIAL ANALYSIS OF THE EXPLANTED COMPONENTS CONCLUDED THE MECHANISMS OF DAMAGE WERE CONSISTENT WITH LOSS OF TAPER LOCK BETWEEN THE ACCOLADE FEMORAL STEM AND V40 COCR LFIT FEMORAL HEAD." ADDITIONAL INFORMATION, INCLUDING HISTOPATHOLOGY REPORTS, ARE NEEDED TO FURTHER INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS' HIP WAS REVISED. ORIGINALLY, THE REASON FOR REVISION WAS A FRACTURED TRUNNION. INTRA-OPERATIVELY, IT WAS REPORTED THAT THE HEAD FRETTED ON THE TRUNNION EVENTUALLY FRACTURING THE TRUNNION, PRESENCE OF METALLOSIS WAS NOTED WITH BLACK TISSUE BEING VISIBLE.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED RELEVANT DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENTS' HIP WAS REVISED. ORIGINALLY, THE REASON FOR REVISION WAS A FRACTURED TRUNNION. INTRA-OPERATIVELY, IT WAS REPORTED THAT THE HEAD FRETTED ON THE TRUNNION EVENTUALLY FRACTURING THE TRUNNION, PRESENCE OF METALLOSIS WAS NOTED WITH BLACK TISSUE BEING VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481672 ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 25764204 04546540510761

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R