BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 BISPHERICAL SHELL 52E

    MDR report key: 8412626 · Received March 12, 2019

    Report

    Report Number
    3002806535-2019-00266
    Event Type
    Injury
    Date Received
    March 12, 2019
    Date of Event
    February 14, 2019
    Report Date
    November 12, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWZ
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL PRODUCT: G7 DUAL MOBILITY LINER 42MM E ITEM #: 110024463 LOT #: 933100. MEDICAL PRODUCT: ACT ARTIC E1 HIP BRG 28X42MM ITEM #: EP-200148 LOT #: UNKNOWN. MEDICAL PRODUCT: FORTE CER FM HD D28/+3.5 12/14 ITEM #: 164192 LOT #: UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. CORRECTED SECTION: 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.

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTED INFORMATION: CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: G7 DUAL MOBILITY LINER 42MM E ITEM #: 110024463 LOT #: 933100. MEDICAL PRODUCT: ACT ARTIC E1 HIP BRG 28X42MM ITEM #: EP-200148 LOT #: UNKNOWN. MEDICAL PRODUCT: FORTE UNKNOWN BIOLOX DELTA CERAMIC HEADCER FM HD D28/+3.5 12/14 ITEM #: UNKNOWN LOT #: UNKNOWN. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REVISED COMPONENTS WERE IN USE FOR APPROXIMATELY 6 MONTHS AND 29 DAYS. THE EXTERNAL SURFACE OF THE REVISED ACETABULAR SHELL PRESENT LACK OF BONE INTEGRATION. MARKS ON THE NON-ARTICULATING SURFACE OF THE COCR METAL LINER SUGGEST THAT THE SCREWS MIGHT NOT HAVE BEEN FULLY SEATED. IT ALSO SUGGESTS THE RELATIVE MOVEMENT BETWEEN THE SHELL AND THE COCR LINER, WHICH IS CONSISTENT WITH THE REPORTED EVENT ¿THE LOOSENING OF THE IMPLANT. WEAR PATCHES OBSERVED ON THE ARTICULATING SURFACE OF THE COCR LINER AND SCRATCHES AND PITTING OBSERVED ON THE E1 DUAL MOBILITY LINER INDICATE THE PRESENCE OF THIRD BODY PARTICLES WITHIN THE JOINT SPACE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED IN THE COMPLAINT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO DISASSOCIATION OF IMPLANT.

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO DISASSOCIATION OF IMPLANT.

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO DISASSOCIATION OF IMPLANT.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    HIP REVISION SURGERY DUE TO DISASSOCIATION OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207944 G7 BISPHERICAL SHELL 52E HIP PROSTHESIS KWZ BIOMET UK LTD. N/A 3897080

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R