BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/-3MM

    MDR report key: 7475691 · Received May 1, 2018

    Report

    Report Number
    3002806535-2018-00761
    Event Type
    Injury
    Date Received
    May 1, 2018
    Date of Event
    November 28, 2016
    Report Date
    May 1, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PK131684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 14-103656, UNIV 2-HOLE SHL 56MM LNR SZ 24, 619240, EP-105994, EPOLY 36MM RLC LNR MROM SZ24 ZE 24, 882430, 51-106120, TPRLC 133 MP TYPE1 PPS SO 12.0, 3455265, UNKNOWN, UNKNOWN SCREW, UNKNOWN, UNKNOWN, UNKNOWN SCREW, UNKNOWN. REPORT SOURCE, FOREIGN - THE EVENT OCCURRED IN (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION, THEREFORE A VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORT EVENT WAS NOT REPORTED. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PROCEDURE THE PATIENT REPORTED EXPERIENCING PROBLEMS WALKING ABOUT, PROBLEMS WITH WASHING/DRESSING SELF, PROBLEMS WITH USUAL ACTIVITIES, AND MODERATE PAIN DURING THE SIX-MONTH FOLLOW-UP. ADDITIONALLY, DURING A ONE-YEAR POST-OPERATIVE FOLLOW-UP, IT WAS REPORTED THAT THE PATIENT CONTINUED TO EXPERIENCE PROBLEMS WALKING ABOUT, PROBLEMS WITH USUAL ACTIVITIES, AND MODERATE PAIN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318766 DELTA CERAMIC FEM HD 36/-3MM PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 2015080065

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other