BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD MOD HD 32MM STD NK

    MDR report key: 9614980 · Received January 22, 2020

    Report

    Report Number
    3002806535-2020-00030
    Event Type
    Injury
    Date Received
    January 22, 2020
    Date of Event
    August 13, 2019
    Report Date
    February 6, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00880304438804
    PMA / PMN Number
    K042091
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE FOLLOWING SECTIONS WERE UPDATED: B4, D10, D11, G4, H2, H3, H6. 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 HAS BEEN REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY THE PATIENT HAS RECEIVED TWO REVISIONS, BOTH FOR UNKNOWN REASONS. THIS COMPLAINT IS REPORTING THE SECOND REVISION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT:ECHO POR FEM RED LAT NC 11X135, CATALOG #: 192511, LOT #: 741870, MEDICAL PRODUCT: G7 OSSEOTI 3 HOLE SHELL 50MM D, CATALOG #: 110010243, LOT #: 6214131, MEDICAL PRODUCT: G7 NEUTRAL E1 LINER 32MM D, CATALOG #: 010000848, LOT #: 6148277. 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 HAS BEEN REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY THE PATIENT HAS RECEIVED TWO REVISIONS, BOTH FOR UNKNOWN REASONS. THIS COMPLAINT IS REPORTING THE SECOND REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78278 CER BIOLOXD MOD HD 32MM STD NK HIP ARTHROPLASTY LZO BIOMET UK LTD. N/A 117110 00880304438804

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R