BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPOLY 36MM RNGLC LNR HW SZ25

    MDR report key: 3882708 · Received June 19, 2014

    Report

    Report Number
    0001825034-2014-05600
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    July 3, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK070399
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO LIKELY BE DUE TO THE SURGICAL ASSEMBLY DIFFICULTY OF PARTS THAT ARE AT MINIMUM CLEARANCE FAILURE TO ASSURE THE LINER WAS LOCKED DURING INSERTION. HOWEVER, WITHOUT BOTH PARTS OF THE ASSEMBLY, AN ABSOLUTE CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS IT STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND/OR FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. DURING THE PROCEDURE, THE LINER DISENGAGED FROM THE ACETABULAR CUP. SURGEON ATTEMPTED TO LOCK THE LINER AGAIN BUT WAS UNSUCCESSFUL. A NEW LOCKING RING AND LINER WERE UTILIZED TO COMPLETE THE PROCEDURE. A 35 MINUTE DELAY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361585 EPOLY 36MM RNGLC LNR HW SZ25 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 269480

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R