BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC-X E1 H/W 58/36MM 25

    MDR report key: 6432369 · Received March 24, 2017

    Report

    Report Number
    3002806535-2017-00175
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    April 6, 2016
    Report Date
    May 25, 2017
    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
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). (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) K023357. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. 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: 0001825034-2017-01998, 0001825034-2017-01999, 0001825034-2017-02002 AND 0001825034-2017-02003.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION, THIS EVENT WAS DETERMINED TO NOT BE REPORTABLE AS IT WAS NOT DEVICE OR PROCEDURE RELATED. THE INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALLEGED EXPERIENCING LEFT HIP TROCHANTERIC MUSCLE PAIN, LOWER BACK PAIN AND DECREASED FUNCTION APPROXIMATELY ONE YEAR POST-IMPLANTATION. PATIENT HAS UNDERGONE PHYSICAL THERAPY. NO REVISION IS PLANNED. ATTEMPTS HAVE BEEN MADE, BUT NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALLEGED EXPERIENCING LEFT HIP TROCHANTERIC MUSCLE PAIN, LOWER BACK PAIN AND DECREASED FUNCTION APPROXIMATELY ONE YEAR POST-IMPLANTATION. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE, BUT NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213691 RINGLOC-X E1 H/W 58/36MM 25 PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 3444987

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other ARCOS INTERLOCKING DISTAL STEMS| REGENERX RINGLOC + MODULAR ACETABULAR SHELLS| RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS