BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 HI-WALL E1 LINER 36MM G

    MDR report key: 16626612 · Received March 28, 2023

    Report

    Report Number
    0001825034-2023-00643
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    March 3, 2023
    Report Date
    April 21, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE NOT REVIEWED, AS NO PRODUCT LOT INFORMATION WAS PROVIDED. ALL DEVICES MANUFACTURED FOLLOW ACCEPTABLE STERILIZATION PROCESSES ACCORDING TO PUBLISHED ISO/AAMI/ASTM & EU GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS NO PRODUCT INFORMATION WAS PROVIDED, VALIDATION OF STERILE CERTIFICATIONS CANNOT BE PERFORMED; THEREFORE, THE REPORTED DEVICE CANNOT BE EXCLUDED AS A POSSIBLE SOURCE OF THE REPORTED INFECTION. 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). REPORT SOURCE: AUSTRALIA. CONCOMITANT MEDICAL PRODUCTS: CAT #: 110010267/ G7 OSSEOTI MULTIHOLE 58MM G / LOT #: 7034610. CAT#: 010000998 / G7 SCREW 6.5MM X 25MM / LOT #: 7022124. CAT #: 010001002 / G7 SCREW 6.5MM X 45MM / LOT #: 7070385. CAT #: 00811400210 / FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 2 130 MM STEM LENGTH / LOT #: 65532457. CAT #: 00801803605 / FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER / LOT #: 62969812. CAT #: 00801102024 / ALLEN MEDULLARY CEMENT PLUGS 1-24 MM DIAMETER FLANGE/12 MM DIAMETER CORE STORE IN COOL DRY PLACE / 65532457. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A HEAD AND LINER EXCHANGE PROCEDURE 29 DAYS POST IMPLANTATION DUE TO AN INFECTION. ALL OF THE COMPONENTS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9640 G7 HI-WALL E1 LINER 36MM G PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male Required Intervention| H