BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC MODULAR ACETABULAR SYSTEM

    MDR report key: 16635869 · Received March 29, 2023

    Report

    Report Number
    0009610576-2023-00001
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    January 1, 2015
    Report Date
    March 28, 2023
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    LPH
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: REF. 1076-23, LOT UNKNOWN, DESCRIPTION: RINGLOC 10 ARCOM PLASTIC C 32 I/D-SIZE 23, REF. 1010-35, LOT UNKNOWN, DESCRIPTION: CERAMIC FEMORAL HEAD 12/14 32MM S. REPORT SOURCE: FOREIGN - SPAIN. STUDY - CLINICAL STUDY. PMA/510K - 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 K030055.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A RETROSPECTIVE CLINICAL STUDY THAT CHRONIC PYOMIOSIS AND PSOAS ABCS OCCURRED 4 YEARS AFTER THE SURGERY, REQUIRING CHIRURGICAL DRAINAGE WITHOUT OPENING THE JOINT CAPSULE. THE SURGEON INDICATED THAT THIS ADVERSE EVENT WAS POSSIBLY RELATED TO THE DEVICE. THE COMPLICATION WAS RESOLVED ON APRIL 8, 2015. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2008072 RINGLOC MODULAR ACETABULAR SYSTEM HIP PROSTHESIS LPH BIOMET SPAIN, S.L. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization