BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 VIT E HIGH WALL LNR 40MM G

    MDR report key: 18132104 · Received November 14, 2023

    Report

    Report Number
    0001822565-2023-03156
    Event Type
    Injury
    Date Received
    November 14, 2023
    Date of Event
    October 2, 2023
    Report Date
    February 13, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024520554
    PMA / PMN Number
    K190660
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 00877504004 LOT# 3141169 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, XL, ø 40/+7, TAPER 12/14. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 ADDITIONAL INFORMATION. CORRECTED: CLINICAL CODE. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED GOUGES ON THE HIGH WALL RIM AND IN THE INNER SPHERICAL SURFACE. TOP OF THE OUTER SPHERICAL SURFACE SHOWS WEAR AND DEFORMATION. THE ANTI ROTATION SCALLOPS, CUTOUTS, AND GROOVE ON THE OUTER SPHERICAL SURFACE ARE WORN AWAY ON ONE SIDE OF THE OUTER SPHERICAL SURFACE. REMAINING ANTI ROTATION SCALLOPS, CUTOUTS, AND GROOVE EXHIBIT DEFORMATION, GOUGES, AND BURRS ALONG THE CIRCUMFERENCE EDGE. NO OTHER DAMAGE WAS NOTED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO USER ERROR, AS THE SURGEON ACKNOWLEDGED THAT THE LINER WAS NOT PROPERLY ASSEMBLED TO THE SHELL. AS PER IFU 87-6200-020-23, MALALIGNMENT OF THE COMPONENTS OR INACCURATE IMPLANTATION CAN LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE. THIS COMPLAINT WAS CONFIRMED BASED ON THE DAMAGE TO THE RETURNED DEVICE. 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 POSTOPERATIVE X-RAY SHOWED THE FEMORAL HEAD NOT SITTING IN THE CENTER OF THE ACETABULAR COMPONENT. A REVISION SURGERY OCCURRED TO REPLACE THE HEAD AND LINER AND IT WAS NOTICED THE HEAD WAS NOT PROPERLY LOCKED INTO THE LINER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1978655 G7 VIT E HIGH WALL LNR 40MM G PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 66152419 00889024520554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H10 NARRATIVE.