BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL RINGLOC ACETABULAR LINER

    MDR report key: 6178147 · Received December 15, 2016

    Report

    Report Number
    0001825034-2016-05220
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 29, 2016
    Report Date
    July 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK042051
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT - UNKNOWN FEMORAL HEAD, UNKNOWN FEMORAL STEM, UNKNOWN ACETABULAR CUP.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - NI. DEVICE PRODUCT CODE - NI. EXPIRATION DATE - NI. DATE IMPLANTED - NI. DATE EXPLANTED - NI. INITIAL REPORTER - NI. MANUFACTURE DATE ¿ NI.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: ECHO BI-METRIC RED PROXIMAL PROFILE P/N 192411 L/N 303470; RINGLOC SHELL P/N 16-104148 L/N 937350; COCR MODULAR HEAD P/N 163674 L/N 120980; APICAL HOLE PLUG P/N 123741 L/N 198190; RINGLOC DOME SCREW HOLE PLUG P/N 16-116082 L/N 527620; RINGLOC DOME SCREW HOLE PLUG P/N 16-116082 L/N 260010. THERAPY DATE UNKNOWN. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. RADIOGRAPHIC REVIEW FOUND NO EVIDENCE OF WEAR, LOOSENING OR OTHER MALFUNCTION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 PATIENT UNDERWENT A REVISION PROCEDURE DUE TO POLY WEAR. DURING THE PROCEDURE, THE ACETABULAR LINER AND FEMORAL HEAD WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    A REVISION PROCEDURE HAS BEEN INDICATED DUE TO AN UNKNOWN REASON; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826393 ARCOM XL RINGLOC ACETABULAR LINER PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 312310

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R