BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL E1 LINER 36MM G

    MDR report key: 15469639 · Received September 23, 2022

    Report

    Report Number
    0001825034-2022-02193
    Event Type
    Injury
    Date Received
    September 23, 2022
    Date of Event
    April 26, 2018
    Report Date
    November 4, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304526440
    PMA / PMN Number
    K121874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT #: 136536320 / J&J DELTA-HEAD CERAMIC / LOT #: 8759257. CAT #: 157011150 / J&J STEM, SUMMIT / LOT #: HP3561. CAT #: 010000666 /G7 PPS LTD ACET SHELL/LOT #:6217068. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-02194 THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO THE DEVICE REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, AS SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D4; G3; H2; H3; H4; H6 COMPLAINT WAS CONFIRMED VIA MEDICAL RECORDS REVIEWED BY A HEALTH CARE PROFESSIONAL. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT IS NOTED THAT ZIMMER BIOMET PRODUCTS WERE USED IN CONJUNCTION WITH A COMPETITOR DEVICE. ZIMMER BIOMET HAS NOT CONFIRMED THE COMPATIBILITY OF THE REPORTED COMBINATION OF DEVICES, AND THESE WOULD BE CONSIDERED OFF-LABEL USAGES. HOWEVER, IT CANNOT BE CONFIRMED THAT THE COMBINATION OF THE JOHNSON AND JOHNSON AND ZIMMER BIOMET PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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 THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, ON AN UNKNOWN DATE, PATIENT STARTED TO EXPERIENCE PAIN, DIFFICULTY WALKING AND TROUBLE SLEEPING FOR LONG PERIODS OF TIME. NO PLAN FOR REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2728429 G7 NEUTRAL E1 LINER 36MM G PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. NI 6227064 00880304526440

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Other