BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOM XL HI-WALL LINER RINGLOC-X SZ 46MM (RINGLOC SIZE 22)

    MDR report key: 5834823 · Received July 29, 2016

    Report

    Report Number
    3002806535-2016-00634
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Date of Event
    June 28, 2016
    Report Date
    October 1, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. 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. PMA 510(K): THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K023357. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2016-00634 / 00635). PRODUCT REQUESTED, NOT YET RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF MANUFACTURING HISTORY FOUND NO EVIDENCE OF PRODUCT NONCONFORMANCE. EVALUATION OF THE RETURNED LINER REVEALED THAT IT WAS WELL SEATED IN THE SHELL WITH NO MOVEMENT, INDICATING THE LINER AND SHELL COMBINATION WERE CORRECT. A ROOT CAUSE COULD NOT BE DETERMINED AND THE COMPLAINT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE ACETABULAR LINER WOULD NOT ASSEMBLE CORRECTLY WITH THE ACETABULAR SHELL DURING THE PROCEDURE. THERE WAS NO DELAY IN PROCEDURE OR PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT ACETABULAR LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485607 ARCOM XL HI-WALL LINER RINGLOC-X SZ 46MM (RINGLOC SIZE 22) PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 3664781

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR