BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SZ 24 RINGLOC+ IMPACTOR PLATE

    MDR report key: 4836325 · Received June 10, 2015

    Report

    Report Number
    0001825034-2015-02450
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    May 11, 2015
    Report Date
    August 4, 2015
    Manufacturer
    ZHEJIANG BIOMET MEDICAL PRODUCTS CO., LTD
    Product Code
    HWA
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. EVALUATION OF DEVICE FOUND EVIDENCE THAT FAILURE MODE WAS DUE TO THE IMPACTOR BEING POSITIONED AT AN ANGLE DURING CUP IMPACTION, WHICH MAY HAVE CAUSED THE IMPACTOR NOT TO RELEASE THE ACETABULAR CUP.

    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 CARE AND HANDLING OF INSTRUMENTS, NUMBER 1 STATES, "SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FOR A VARIETY OF REASONS INCLUDING PROLONGED USE, MISUSE, ROUGH OR IMPROPER HANDLING." EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2015. DURING THE PROCEDURE, THE SURGEON IMPACTED THE ACETABULAR CUP; HOWEVER, ONCE IMPLANTED THE INSTRUMENT WOULD NOT RELEASE THE CUP. AS A RESULT, THE CUP HAD TO BE REMOVED AND THE SURGEON HAD TO REAM FOR A LARGER SIZE CUP TO BE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378293 SZ 24 RINGLOC+ IMPACTOR PLATE IMPACTOR HWA ZHEJIANG BIOMET MEDICAL PRODUCTS CO., LTD N/A ZB100701

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention