BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIZE 3 ACCOLADE II 127 DEG

    MDR report key: 7478894 · Received May 2, 2018

    Report

    Report Number
    0002249697-2018-01288
    Event Type
    Injury
    Date Received
    May 2, 2018
    Date of Event
    April 3, 2018
    Report Date
    May 2, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K143085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO SIMILAR EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE SURGEON REVISED ALL THE IMPLANTS FROM A LEFT MAKO HIP DONE ON (B)(6) 2016. HE REVISED DUE TO A FIBROUS INGROWTH DISTAL TO THE STEM. THE PRIMARY HARM INVOLVED IS LOSS OF FIXATION FEMORAL STEM IN A THA. ALTHOUGH THE FEMORAL COMPONENT ON THE XRAYS REVIEWED APPEARS SLIGHTLY UNDERSIZED IT APPEARS WELL FIXED WITH PRISTINE PROSTHETIC BONE INTERFACES. HE DECIDED TO CUT THE CUP OUT AS WELL EVEN THOUGH IT WAS DETERMINED TO BE WELL FIXED. THERE IS INSUFFICIENT DOCUMENTATION PRESENTED TO COMPLETE THIS ASSESSMENT. FURTHER DOCUMENTATION WHICH WOULD AID IN ITS COMPLETION WOULD INCLUDE: OPERATIVE REPORT FROM REVISION SURGERY, SURGICAL IMPLANT RECORDS FROM THE REVISION SURGERY, LABORATORY REPORTS, SURGICAL PATHOLOGY REPORTS, DATED PRE AND POST OP XRAYS FROM THE INDEX AND REVISION SURGERIES, OUTPATIENT OFFICE/CLINIC NOTES, IMPLANT RETRIEVAL. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    THE SURGEON REVISED ALL THE IMPLANTS FROM A LEFT MAKO HIP DONE ON (B)(6) 2016. HE REVISED DUE TO A FIBROUS INGROWTH DISTAL TO THE STEM. HE DECIDED TO CUT THE CUP OUT AS WELL EVEN THOUGH IT WAS DETERMINED TO BE WELL FIXED. UPDATE: (B)(6) 2018: AS REPORTED BY REP: "...PATIENT WAS EXPERIENCING THIGH PAIN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322526 SIZE 3 ACCOLADE II 127 DEG PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 52808603

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R