BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI SOLIDBACK CUP 62MM

    MDR report key: 4140448 · Received October 3, 2014

    Report

    Report Number
    0002249697-2014-03754
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    March 23, 2014
    Report Date
    March 25, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISLOCATION DUE TO A MALPOSITIONED SHELL INVOLVING A PRIMARY TRITANIUM HEMI SOLIDBACK CUP 62MM WAS REPORTED. THE EVENT WAS CONFIRMED. A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS MET SPECIFICATIONS. A COMPLAINT HISTORY REVIEW CONFIRMED NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. THE DEVICE WAS NOT RETURNED. A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED: ¿X-RAYS SHOW AN ACCOLADE STEM IN CORRECT POSITION BUT THE TRIDENT CUP HAS A LOW INCLINATION OF 36° WHILE ANTEVERSION IS CLOSE TO 0°. PRINCIPAL ROOT CAUSE OF FAILURE WAS CUP MALPOSITION LEADING TO IMPINGEMENT AND RECURRENT DISLOCATION. BECAUSE CUP POSITION WAS THE PRINCIPAL PROBLEM AND THE SURGEON IS RESPONSIBLE FOR OPTIMAL COMPONENT PLACEMENT, PRINCIPAL ROOT CAUSE OF FAILURE IS PROCEDURE RELATED. THE INVESTIGATION CONCLUDED THAT THE DISLOCATION WAS CAUSED BY SHELL MALPOSITION. NO INDICATIONS FOR PRESENCE OF DEVICE RELATED FACTORS WERE SEEN AND AS SUCH ROOT CAUSE OF FAILURE IS NOT DEVICE RELATED. DEVICE IMPLANTED.

    Description of Event or Problem · 1

    THE CLINICAL STUDY INVESTIGATOR REPORTED VIA THE CLINICAL RESEARCH ASSOCIATE, THAT THE PATIENT WAS ADMITTED TO HOSPITAL AND UNDERWENT A MANIPULATION PROCEDURE OF THEIR HIP REPLACEMENT UNDER ANAESTHETIC ON (B)(6) 2014. THE PATIENT IS CURRENTLY A PARTICIPANT IN A (B)(6) CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618754 PRIMARY TRITANIUM HEMI SOLIDBACK CUP 62MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MJANL3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other