BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BI-METRIC COLLARLESS STEM

    MDR report key: 7056728 · Received November 23, 2017

    Report

    Report Number
    3002806535-2017-01106
    Event Type
    Injury
    Date Received
    November 23, 2017
    Report Date
    November 23, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CONCOMITANT MEDICAL PRODUCT - UNKNOWN M2A 38 FLARED SHELL - BIOMET ORTHOPEDICS LLC MANUFACTURED, UNKNOWN FEMORAL HEAD - BIOMET ORTHOPEDICS LLC MANUFACTURED. HUGHES R.E., BATRA A., HALLSTROM B.R. (2017) "ARTHROPLASTY REGISTRIES AROUND THE WORLD: VALUABLE SOURCES OF HIP IMPLANT REVISION RISK DATA.", CURRENT REVIEWS MUSCULOSKELETAL MEDICINE (2017) 10:240¿252, HTTPS://WWW.NCBI.NLM.NIH.GOV/PMC/ARTICLES/PMC5435639/. THE PURPOSE OF THIS PAPER IS TO BRIEFLY DESCRIBE ARTHROPLASTY REGISTRY CONCEPTS, INTERNATIONAL REGISTRIES AROUND THE WORLD, US REGISTRIES, AND PROVIDE A PARSIMONIOUS SUMMARY OF TOTAL HIP ARTHROPLASTY (THA) IMPLANT REVISION RISK REPORTS ACROSS REGISTRIES. THE PRODUCT AND LOT NUMBER IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY AND THE COMPLAINT HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED IN A JOURNAL ARTICLE THAT 1,944 BI-METRIC COLLARLESS STEM AND M2A 38 FLARED CUP (UNCEMENTED IMPLANTS) REVISIONS DUE TO UNKNOWN REASONS WERE PERFORMED. THE DATA WAS OBTAINED FROM THE (B)(6) NATIONAL JOINT REGISTRY FOR THE PAST 10 YEARS. ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ON THE REPORTED EVENTS, HOWEVER NO INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834574 UNKNOWN BI-METRIC COLLARLESS STEM HIP PROSTHESIS JDI BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R