BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 BISPHERICAL SHELL 52E

    MDR report key: 8953636 · Received September 2, 2019

    Report

    Report Number
    3002806535-2019-00723
    Event Type
    Injury
    Date Received
    September 2, 2019
    Date of Event
    August 12, 2019
    Report Date
    November 8, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 A PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE SURGEON REMOVED THE DEVICE AND IMPLANTED A SPACER DUE TO SEPTIC CUP LOOSENING.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ASSOCIATED PRODUCTS MEDICAL PRODUCT: BIOLOX DELTA CER LNR 36MM E CATALOG #: 110003634 LOT #: 6091377, MEDICAL PRODUCT: TAPERLOC BMPC 9.0X137MM 12/14 CATALOG #: 650-0552BM LOT #: 6170697, MEDICAL PRODUCT: BIOLOX DELTA HEAD 12/14 36X0 CATALOG #: 00-8775-036-02 LOT #: 2017090229. 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 INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE SURGEON REMOVED THE DEVICE AND IMPLANTED A SPACER DUE TO SEPTIC CUP LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747852 G7 BISPHERICAL SHELL 52E HIP PROSTHESIS JDI BIOMET UK LTD. N/A 3892836

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R