BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC-X ARCOMXL H/W 52/32MM

    MDR report key: 7326433 · Received March 9, 2018

    Report

    Report Number
    3002806535-2018-00422
    Event Type
    Injury
    Date Received
    March 9, 2018
    Date of Event
    January 10, 2017
    Report Date
    April 26, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - EXC ABT RNGLC-X SHELL PC 052MM, ITEM 131352, LOT 2902081 (STILL IMPLANTED). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). 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: 3002806535-2018-0421.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 THE PATIENT UNDERWENT PARTIAL TYPE OF HIP ARTHROPLASTY AND SUBSEQUENTLY THE PATIENT HAD PAIN IN LATERAL SIDE OF HIP. THE PATIENT WAS ALSO DIAGNOSED WITH TROCHANTER BURSITIS AND TREATED WITH STEROID INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171061 RINGLOC-X ARCOMXL H/W 52/32MM LPH BIOMET UK LTD. N/A 3306130

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention