BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL HI-WALL LINER RINGLOC-X

    MDR report key: 6848471 · Received September 7, 2017

    Report

    Report Number
    3002806535-2017-00887
    Event Type
    Injury
    Date Received
    September 7, 2017
    Date of Event
    August 11, 2017
    Report Date
    January 25, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN ¿ EVENT OCCURRED IN (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K023357. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-06868.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY, A LINER WOULD NOT SEAT IN THE SHELL. THE SHELL AND LINER WERE REMOVED FROM THE PATIENT AND ANOTHER SHELL AND LINER WERE USED TO COMPLETE THE PROCEDURE. UPON REMOVAL OF THE SHELL, IT WAS FOUND THE LOCKING RING COULD NOT ROTATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628189 ARCOM XL HI-WALL LINER RINGLOC-X PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 3879059

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention UNIVERSAL SHELL PN14-103650 LN040680