BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/-3MM

    MDR report key: 7426714 · Received April 12, 2018

    Report

    Report Number
    3002806535-2018-00702
    Event Type
    Injury
    Date Received
    April 12, 2018
    Date of Event
    December 15, 2014
    Report Date
    April 12, 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: 14-103660, UNIV 2-HOLE SHL 60 MM LNR SZ 25, 408880. EP-105995, EPOLY 36 MM RLC LNR MROM SZ25 ZE 25, 919920. THE 51-106100, TPRLC 133 MP TYPE1 PPS SO 10.0, 2685453. UNKNOWN, UNKNOWN SCREW, UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT HIP SURGERY. SUBSEQUENTLY, THE PATIENT REPORTED POSTOPERATIVE MODERATE PAIN, DISCOMFORT, PROBLEMS WALKING ABOUT, PROBLEMS WITH WASHING/DRESSING SELF, AND PROBLEMS WITH USUAL ACTIVITIES AT THE SIX MONTH AND ONE-YEAR FOLLOW-UP VISITS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269488 DELTA CERAMIC FEM HD 36/-3MM PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 3164060

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other