BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4583282 · Received March 9, 2015

    Report

    Report Number
    0002249697-2015-00654
    Event Type
    Injury
    Date Received
    March 9, 2015
    Date of Event
    February 11, 2015
    Report Date
    February 11, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING WEAR AND ALTR INVOLVING AN ACCOLADE STEM AND A METAL HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW WAS NOT PERFORMED AS THE LOT ID IS UNKNOWN. COMPLAINT HISTORY REVIEW WAS NOT PERFORMED AS THE LOT ID IS UNKNOWN. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS DEVICE RETURN, X-RAYS, PATHOLOGY REPORTS, OPERATIVE REPORTS AND PATIENT MEDICAL RECORDS WOULD BE HELPFUL IN INVESTIGATING THIS EVENT FURTHER. IF ADDITIONAL INFORMATION AND/OR DEVICE BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN ACCOLADE TMZF 4.5. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. HOSPITAL POLICY.

    Description of Event or Problem · 1

    THE SURGEON INITIALLY SUSPECTED DISLOCATION HOWEVER, A REVISION OF A RIGHT HIP REVEALED THAT THE METAL HEAD WORE DOWN THE TRUNNION OF THE STEM. THE STEM, HEAD AND LINER WERE REVISED. THE SURGEON NOTED ALTR IN THE SOFT TISSUE.

    Description of Event or Problem · 1

    THE SURGEON INITIALLY SUSPECTED DISLOCATION HOWEVER, A REVISION OF A RIGHT HIP REVEALED THAT THE METAL HEAD WORE DOWN THE TRUNNION OF THE STEM. THE STEM, HEAD AND LINER WERE REVISED. THE SURGEON NOTED ALTR IN THE SOFT TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162599 ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5 IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention