BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5

    MDR report key: 7541985 · Received May 24, 2018

    Report

    Report Number
    0002249697-2018-01574
    Event Type
    Injury
    Date Received
    May 24, 2018
    Date of Event
    January 28, 2014
    Report Date
    May 24, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PRODUCT HISTORY RECORDS INDICATES THAT PRODUCTS WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    NOTICE RECEIVED FROM PATIENT'S ATTORNEY ALLEGES THAT PATIENT HAD A STRYKER HIP PROSTHESIS REVISION. UPDATED PER MEDICAL REVIEW: "ON (B)(6) 2014 A REVISION OF THE LEFT ACETABULUM WAS PERFORMED FOR A DIAGNOSIS OF "INSTABILITY LEFT TOTAL HIP". THE OPERATIVE REPORT DESCRIBES SPINAL ANESTHESIA AND A POSTEROLATERAL APPROACH. THE OPERATIVE REPORT NOTES, "HEAD REMOVED, NECK A LITTLE BIT OF METALLOSIS, CLEANED WITH A SPONGE, LINER WAS SNAPPED OUT; BOTH IMPLANTS WERE VERY SECURE. "UNCOMPLICATED SURGERY WAS DESCRIBED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385397 ACCOLADE (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 18606903

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R