BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/-3MM

    MDR report key: 9304324 · Received November 11, 2019

    Report

    Report Number
    3002806535-2019-00863
    Event Type
    Injury
    Date Received
    November 11, 2019
    Date of Event
    August 13, 2016
    Report Date
    February 6, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE FOLLOWING SECTIONS WERE UPDATED: B4, G4, H2, H3, H6. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. THE STERILISATION CERTIFICATES WERE REVIEWED AND CONFIRMED THAT THE PRODUCT IS STERILISED WITHIN THE SPECIFICATION RANGE. 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. H3 OTHER TEXT : PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP ATHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED A DEEP INFECTION.

    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 SZ24 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 IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP ATHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED A DEEP INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097648 DELTA CERAMIC FEM HD 36/-3MM HIP PROSTHESIS JDI BIOMET UK LTD. N/A 2015080065

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization