BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5623972 · Received May 2, 2016

    Report

    Report Number
    0002249697-2016-01471
    Event Type
    Injury
    Date Received
    May 2, 2016
    Date of Event
    January 1, 2016
    Report Date
    September 9, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REPORTING ALTR INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION WERE NOT PERFORMED AS THE DEVICES REMAINED IMPLANTED. -MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED X-RAYS AND MEDICAL RECORDS WHERE REVIEWED BY A CLINICAL CONSULTANT WHO NOTED THE FOLLOWING: [...] THESE FINDINGS ARE CONSISTENT WITH, BUT NOT DIAGNOSTIC OF, SMALL PARTICLE DISEASE OR AL TR. NO EXAMINATION OF THE EXPLANTED COMPONENTS AND NO DESCRIPTION OF TRUNNION DESTRUCTION OR METALLOSIS STAINING OUTSIDE THE HEAD/NECK JUNCTION IS AVAILABLE. THERE IS NO EXAMINATION OF DARK MATERIAL IN METALLIC HEADS TO RULE OUT BIOLOGIC DEBRIS. BASED UPON THE INFORMATION AVAILABLE FOR REVIEW, NO DETERMINATION CAN BE MADE FOR THE CAUSE OF THIS CLINICAL SITUATION. EXAMINATION OF THE EXPLANTED HEADS AND REVIEW OF THE PATHOHISTOLOGIC SLIDES FROM THE REVISION SURGERIES WOULD BE HELPFUL TO FULLY EVALUATE THIS CASE. DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE MEDICAL REVIEW NOTED THE FOLLOWING: NO EXAMINATION OF THE EXPLANTED COMPONENTS AND NO DESCRIPTION OF TRUNNION DESTRUCTION OR METALLOSIS STAINING OUTSIDE THE HEAD/NECK JUNCTION IS AVAILABLE. THERE IS NO EXAMINATION OF DARK MATERIAL IN METALLIC HEADS TO RULE OUT BIOLOGIC DEBRIS. BASED UPON THE INFORMATION AVAILABLE FOR REVIEW, NO DETERMINATION CAN BE MADE FOR THE CAUSE OF THIS CLINICAL SITUATION. EXAMINATION OF THE EXPLANTED HEADS AND REVIEW OF THE PATHOHISTOLOGIC SLIDES FROM THE REVISION SURGERIES WOULD BE HELPFUL TO FULLY EVALUATE THIS CASE. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 0

    SOLICITORS EMAIL REPORTED THAT THEY HAVE RECENTLY BEEN INSTRUCTED BY A PATIENT WHO HAS SUFFERED THE BILATERAL FAILURE OF HIS METAL ON POLYETHYLENE COMPONENTS DUE TO AN ADVERSE REACTION TO METAL DEBRIS. THIS RECORD RELATED TO THE LEFT HIP.

    Additional Manufacturer Narrative · 1

    AN EVENT REPORTING ALTR INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS NOT PERFORMED AS MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, PATHOLOGY REPORTS, X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    SOLICITORS EMAIL REPORTED THAT THEY HAVE RECENTLY BEEN INSTRUCTED BY A PATIENT WHO HAS SUFFERED THE BILATERAL FAILURE OF HIS METAL ON POLYETHYLENE COMPONENTS DUE TO AN ADVERSE REACTION TO METAL DEBRIS. THIS RECORD RELATED TO THE LEFT HIP.

    Description of Event or Problem · 1

    SOLICITORS EMAIL REPORTED THAT THEY HAVE RECENTLY BEEN INSTRUCTED BY A PATIENT WHO HAS SUFFERED THE BILATERAL FAILURE OF HIS METAL ON POLYETHYLENE COMPONENTS DUE TO AN ADVERSE REACTION TO METAL DEBRIS. THIS RECORD RELATED TO THE LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278935 ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 21499002

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R