BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN C2A-TAPER MODULAR HEAD

    MDR report key: 7431834 · Received April 15, 2018

    Report

    Report Number
    3002806535-2018-00716
    Event Type
    Injury
    Date Received
    April 15, 2018
    Date of Event
    November 26, 2017
    Report Date
    September 7, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO 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 WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: FOREIGN. THE EVENT(S) OCCURRED IN (B)(6). REPORT SOURCE: LITERATURE. BORGWARDT, ARNE, ET AL. ¿A RANDOMIZED SEVEN-YEAR STUDY ON PERFORMANCE OF THE STEMMED METAL M2A-MAGNUM AND CERAMIC C2A-TAPER, AND THE RESURFACING RECAP HIP IMPLANTS.¿ THE JOURNAL OF ARTHROPLASTY, 2017, DOI:10.1016/(B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. [BORGWARDT_2017_RANDOMIZED 7 YR STUDY.PDF]. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A HYPO-ECHOIC AREA LARGER THAN 1 X 1CM AROUND THE JOINT IS NOT AN UNUSUAL FINDING AND DOES NOT GIVE ANY INDICATION FOR SURGERY IF THIS IS THE ONLY FINDING.

    Description of Event or Problem · 1

    IT WAS REPORTED 14 PATIENTS PRESENTED WITH ADVERSE LOCAL TISSUE REACTION (ALTR) LARGER THAN 1X1 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274512 UNKNOWN C2A-TAPER MODULAR HEAD PROSTHESIS, HIP LZO BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UNKNOWN PART/LOT: STEM, CUP, TAPER, BEARING