BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RINGLOC ARCOM LINER

    MDR report key: 6774406 · Received August 8, 2017

    Report

    Report Number
    0001825034-2017-06080
    Event Type
    Injury
    Date Received
    August 8, 2017
    Date of Event
    November 3, 2016
    Report Date
    August 23, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BORGWARDT, A. ET AL (2016) A RANDOMISED, CONTROLLED CLINICAL STUDY ON TOTAL HIP ARTHROPLASTY USING 4 DIFFERENT BEARINGS: RESULTS AFTER 10 YEARS. HIP INTERNATIONAL 2017; 27 (1): 96-103. DOI: 10.5301/HIPINT.5000428. (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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-06086, 0001825034-2017-06088.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICES OR PHOTOS OF THE DEVICES WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. ADDITIONALLY, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE PRODUCT NUMBER AND THE LOT NUMBER WERE NOT PROVIDED; THEREFORE, THE MANUFACTURING DATE, THE DEVICE HISTORY RECORDS AND THE FIELD AGE OF THE DEVICE COULD NOT BE DETERMINED. THERE IS INSUFFICIENT INFORMATION TO PERFORM A COMPLAINT HISTORY SEARCH. A DEFINITIVE ROOT CAUSE COULD NOT 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED 15 PATIENT REVISIONS FOR DISLOCATIONS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556093 UNKNOWN RINGLOC ARCOM LINER PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNKNOWN CO CR HEAD| UNKNOWN M2A RINGLOC LINER