BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI 4 HOLE SHELL 56MM F

    MDR report key: 19380306 · Received May 23, 2024

    Report

    Report Number
    0001825034-2024-01337
    Event Type
    Injury
    Date Received
    May 23, 2024
    Date of Event
    April 29, 2024
    Report Date
    August 26, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00887868355905
    PMA / PMN Number
    K140669
    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. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4; G3; G6; H2; H6 ; H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. XRAY REVIEWED AND NOT SUBMITTED TO MMI FOR ASSESSMENT AS THIS WOULD NOT ENHANCE THE INVESTIGATION. THE ALLEGATION IS RELATED TO PAIN/DISCOMFORT (NOT AN OBSERVABLE/CONFIRMABLE SYMPTOM ON IMAGING) RELATED TO INCREASED LEG LENGTH (FULL LENGTH LEG IMAGES NOT PROVIDED) AND OFFSET FROM INITIAL SURGERY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 51-117100 ITEM NAME TPRLC 133 MP TYPE1 BM HO 10.0 LOT # 6886974. 010000858 ITEM NAME G7 NEUTRAL E1 LINER 36MM F LOT# 7252593. G2: FOREIGN: AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; 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

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 1 YEAR AND 8 MONTHS POST IMPLANTATION DUE TO PAIN AND DISCOMFORT RELATED TO INCREASED LEG LENGTH AND OFFSET FROM PRIMARY HIP SURGERY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570560 G7 OSSEOTI 4 HOLE SHELL 56MM F PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 7250824 00887868355905

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Hospitalization| R