BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC ACETABULAR LINER 32MM/ 10 DEGREE SIZE 24

    MDR report key: 6619219 · Received June 7, 2017

    Report

    Report Number
    0001825034-2017-03690
    Event Type
    Injury
    Date Received
    June 7, 2017
    Date of Event
    May 11, 2017
    Report Date
    September 20, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK023357
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN CUP, UNKNOWN HEAD, UNKNOWN STEM.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-104154 565200 MLRY-HD 3HOLE RLC SHL 54MM/L24, UNKNOWN HEAD, UNKNOWN STEM, 565200 266805 TI LOW PROFILE SCREW 6.5X25MM, 103531 213612 TI LOW PROFILE SCREW 6.5X20MM, 103533 226163 TI LOW PROFILE SCREW 6.5X30MM. COUNTRY: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT¿S HIP WAS REVISED APPROXIMATELY 17 YEARS POST-IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399096 RINGLOC ACETABULAR LINER 32MM/ 10 DEGREE SIZE 24 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO BIOMET ORTHOPEDICS N/A 183800

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 103531 213612 TI LOW PROFILE SCREW 6.5X20MM| 103532 266805 TI LOW PROFILE SCREW 6.5X25MM| 103533 226136 TI LOW PROFILE SCREW 6.5X30MM| 11-104154 565200 MLRY-HD 3HOLE RLC SHL 54MM/L24