BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 DUAL MOBILITY LINER 44MM F

    MDR report key: 8070822 · Received November 14, 2018

    Report

    Report Number
    0001825034-2018-10698
    Event Type
    Injury
    Date Received
    November 14, 2018
    Date of Event
    October 16, 2018
    Report Date
    April 16, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K150522
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI# (B)(4). FOREIGN COUNTRY: (B)(6). REPORTED EVENT WAS CONFIRMED WITH X RAYS PROVIDED. X RAY RESULTS REVEALED DISLOCATION OF THE FEMORAL COMPONENT IN THE SUPEROLATERAL ORIENTATION WITH RESPECT TO THE ACETABULAR CUP. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO RELATED DEVIATIONS/ ANOMALIES WERE IDENTIFIED THAT AFFECT THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. MEDICAL DEVICES: ITEM NUMBER: 00801802803, ITEM NAME: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER, LOT #: 63635050; ITEM NUMBER: 00801802803, ITEM NAME: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER, LOT #: 6178385; ITEM NUMBER: 110010265, ITEM NAME: G7 OSSEOTI MULTIHOLE 54MM FR, LOT #: 6178385; ITEM NUMBER: 010001003, ITEM NAME: G7 SCREW 6.5MM X 50MM, LOT #: 3666645; ITEM NUMBER: 010000999, ITEM NAME: G7 SCREW 6.5MM X 30MM, LOT #: 6301015; ITEM NUMBER: 010000997, ITEM NAME: G7 SCREW 6.5MM X 20MM, LOT #: 6290580; ITEM NUMBER: EP-200150, ITEM NAME: ACT ARTIC E1 HIP BRG 28X44MM, LOT #: 012950. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 10720. 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 · 1

    IT WAS REPORTED PATIENT WAS REVISED APPROXIMATELY ONE MONTH POST-IMPLANTATION DUE TO DISLOCATION. HEAD AND LINER COMPONENTS WERE REMOVED AND EXCHANGED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911234 G7 DUAL MOBILITY LINER 44MM F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 232090

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R