BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5

    MDR report key: 7611375 · Received June 18, 2018

    Report

    Report Number
    0002249697-2018-01866
    Event Type
    Injury
    Date Received
    June 18, 2018
    Date of Event
    January 21, 2009
    Report Date
    August 23, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    04546540510754
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING A PERIPROSTHETIC FRACTURE INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS CONFIRMED FOLLOWING A CLINICIAN REVIEW. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: A CLINICIAN REVIEW WAS PERFORMED WHICH NOTED THERE IS LIMITED INFORMATION AVAILABLE FOR REVIEW SOME OF WHICH IS TRANSLATED FROM ITS NATIVE SWEDISH. PATIENT UNDERWENT AN INDEX PRIMARY THA ON (B)(6) 2009. DURING THIS PROCEDURE A FRACTURE WAS NOTED IN THE CALCAR REGION AFTER STEM IMPLANTATION AND A FIXATION CABLE PLACED. POSTOPERATIVE XRAY FOLLOWING THE INDEX SURGERY SHOWS AN APPARENTLY WELL FIXED THA IN SATISFACTORY POSITION AND ORIENTATION. NOTE IS MADE OF THE CALCAR FIXING CABLE. DEVICE HISTORY REVIEW: THE REVIEW INDICATES THAT THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAS BEEN NO OTHER EVENT FOR THE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PRE & POST OP X-RAYS ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 0

    A REVIEW OF MEDICAL RECORDS BY A CLINICIAN IDENTIFIED A CALCAR FRACTURE: PATIENT UNDERWENT AN INDEX PRIMARY THA ON (B)(6) 2009. DURING THIS PROCEDURE A FRACTURE WAS NOTED IN THE CALCAR REGION AFTER STEM IMPLANTATION AND A FIXATION CABLE PLACED.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THERE HAVE BEEN ONE MORE EVENT FOR THE LOT REFERENCED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A REVIEW OF MEDICAL RECORDS BY A CLINICIAN IDENTIFIED A CALCAR FRACTURE: PATIENT UNDERWENT AN INDEX PRIMARY THA ON (B)(6) 2009. DURING THIS PROCEDURE A FRACTURE WAS NOTED IN THE CALCAR REGION AFTER STEM IMPLANTATION AND A FIXATION CABLE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452725 ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 28141101 04546540510754

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| O| R