BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER FEM HD 28/0MM T1

    MDR report key: 7406538 · Received April 9, 2018

    Report

    Report Number
    3002806535-2018-00676
    Event Type
    Injury
    Date Received
    April 9, 2018
    Date of Event
    December 9, 2015
    Report Date
    April 5, 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). MEDICAL DEVICES: 123748, EXCEED ABT 3HL SHELL 37/48MM, 3120542; 650-0790, BIOLOX DELTA LNR 28MM 46-48MM, 3283248; 51-108080, TPRLC 133 MP T1 PPS SO 8X101MM, 2745471; UNKNOWN, UNKNOWN SCREWS, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT HIP SURGERY. SUBSEQUENTLY, THE PATIENT REPORTED MODERATE PAIN, SOME LIMITATION OF ORDINARY ACTIVITY OR WORK, REQUIRES OCCASIONAL PAIN MEDICINE STRONGER THAN ASPIRIN, MODERATE LIMPING, USE OF TWO CANES, UNABLE TO DO STAIRS, EXTREMELY DIFFICULT TO WASH/DRY, MODERATE TROUBLE GETTING IN OR OUT OF CAR, EXTREMELY DIFFICULT TO PUT ON SOCKS, MODERATELY DIFFICULT TO SHOP, ONLY WALKS AROUND HOUSE BEFORE SEVERE PAIN, EXTREMELY DIFFICULT TO CLIMB STAIRS, VERY PAINFUL TO STAND UP, LIMPING MOST OF THE TIME, GREATLY INTERFERED WITH USUAL WORK, IN BED WITH PAIN MOST NIGHTS AT THE SIX MONTH FOLLOW UP VISIT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250513 DELTA CER FEM HD 28/0MM T1 PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 3232440

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention