BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX PROSTHESIS HEAD 12/14 28MM S

    MDR report key: 2565506 · Received April 27, 2012

    Report

    Report Number
    3005673311-2012-00026
    Event Type
    Malfunction
    Date Received
    April 27, 2012
    Date of Event
    November 28, 2011
    Report Date
    April 18, 2012
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    LWJ
    PMA / PMN Number
    K060918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    U.S. DIVISION NOTIFIED (B)(4) 2012. ADD'L 510 (K): K081973, K083495. ADD'L DETAILS REGARDING THE INCIDENT HAVE BEEN REQUESTED; HOWEVER, THUS FAR, ADD'L INFO NOR PRODUCT REC'D. MFG RECORDS HAVE BEEN CHECKED; ITEMS WERE FOUND TO BE ACCORDING TO THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). BREAKAGE OF CERAMIC HEAD. PRIMARY SURGERY 2002. DATE OF INCIDENT (B)(6) 2011. NO FURTHER INFO REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOLOX PROSTHESIS HEAD 12/14 28MM S LWJ AESCULAP AG & CO. KG NK460 51132407

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other