BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/-3MM

    MDR report key: 8820820 · Received July 24, 2019

    Report

    Report Number
    3002806535-2019-00610
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    August 13, 2016
    Report Date
    September 3, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIMARY LEFT THA PERFORMED. SUBSEQUENTLY PATIENT EXPERIENCED DEEP INFECTION WITH A DURATION OF 77 DAYS. IT WAS REPORTED IT RESOLVED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT:UNIV 2-HOLE SHL 56MM LNR SZ 24 CATALOG #: 14-103656 LOT #: 619240, MEDICAL PRODUCT: EPOLY 36MM RLC LNR MROM SZ 24 ZE 24 CATALOG #: EP-105994 LOT #: 882430, MEDICAL PRODUCT: TPRLC 133 MP TYPE1 PPS SO 12.0 CATALOG #: 51-106120 LOT #: 3455265. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIMARY LEFT THA PERFORMED. SUBSEQUENTLY PATIENT EXPERIENCED DEEP INFECTION WITH A DURATION OF 77 DAYS. IT WAS REPORTED IT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615111 DELTA CERAMIC FEM HD 36/-3MM HIP PROSTHESIS LZO BIOMET UK LTD. N/A 2015080065

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization