BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN M2A RINGLOC LINER

    MDR report key: 6776599 · Received August 9, 2017

    Report

    Report Number
    0001825034-2017-06148
    Event Type
    Injury
    Date Received
    August 9, 2017
    Date of Event
    November 3, 2016
    Report Date
    August 22, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    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. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (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 - 06142, 0001825034 - 2017 - 06144, 0001825034 - 2017 - 06147. - ATTACHMENT: [RIBEL-MADSEN, BORGWARDT ET AL.PDF].

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICE OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE DEVICE IS UNKNOWN. THE PART AND LOT NUMBER OF THE PRODUCT IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS, COMPLAINT HISTORY COULD NOT BE REVIEWED. THE REPORTED DEVICE IS USED FOR TREATMENT. IT COULD NOT BE CONFIRMED IF THE DEVICE WAS USED IN AN APPROVED AND COMPATIBLE COMBINATION. SURGICAL NOTES WERE NOT PROVIDED. IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. RELEVANT MEDICAL HISTORY AND ADHERENCE TO REHABILITATION PROTOCOL ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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.

    Description of Event or Problem · 1

    IT IS REPORTED 1 REVISION CASE FOR INFECTION. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557798 UNKNOWN M2A RINGLOC LINER PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNKNOWN BI METRIC INTERLOC STEM| UNKNOWN CO CR HEAD| UNKNOWN UNIVERSAL RINGLOC LINER