BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FEMORAL HEAD

    MDR report key: 7052254 · Received November 22, 2017

    Report

    Report Number
    3002806535-2017-01090
    Event Type
    Injury
    Date Received
    November 22, 2017
    Report Date
    November 22, 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) . MEDICAL PRODUCT - UNKNOWN BIOMETRIC (TITANIUM) STEM, UNKNOWN TRILOGY (HIGH) CUP (COMPETITOR PRODUCT). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2017-01089.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED IN A JOURNAL ARTICLE THAT 44891 BIOMETRIC (TITANIUM) STEM (UNCEMENTED IMPLANTS) REVISIONS FROM THE DANISH 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
    832163 UNKNOWN FEMORAL HEAD HIP PROSTHESIS JDI BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNKNOWN BIOMETRIC (TITANIUM) STEM| UNKNOWNTRILOGY (HIGH) CUP