BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIRIUS HIP STEM 44-D

    MDR report key: 17189554 · Received June 23, 2023

    Report

    Report Number
    0001825034-2023-01404
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    March 21, 2023
    Report Date
    July 26, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K130610
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 {UPDATE/CORRECTED} UPDATED: D4; G3; H2; H3; H4; H6 COMPONENT CODE: MECHANICAL (G04) ¿ STEM 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 RELATED TO THE REPORTED EVENT. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: MECHANICAL FALL ON GRASS RESULTING IN RIGHT ANKLE FRACTURE. PATIENT FELL WHILST ON A BUS, SEEN IN CLINIC TO CONFIRM MINIMALLY DISPLACED FRACTURE AND NEEDED FURTHER SURGERY FOR FRACTURE OF FEMORAL NECK. REPORTED AS UNRELATED TO DEVICE OR PROCEDURE. PATIENT HAS SUBSEQUENTLY FALLEN MULTIPLE TIMES. AWAITING ANOTHER RIGHT HIP REPLACEMENT DUE TO LOOSENING STEM. PERIPROSTHETIC FRACTURE WAS NOT CONFIRMED. 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). D10: CAT# 11-363662 LOT# 084260 36MM COCR MOD HD STD; CAT# 010000936 LOT# 3819969 G7 HI-WALL E1 LINER 36MM F; CAT# 010000704 LOT# 3771150 G7 BONEMASTER LTD ACET SHL 54F. G2: FOREIGN: UNITED KINGDOM. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. WHILE WAITING FOR REVISION PATIENT TRIPPED AND FELL OUTSIDE ON A DOWNHILL SLOPE AND ONCE AGAIN THE NEXT MORNING WHILE GETTING OUT OF BED. A REVISION OCCURRED APPROXIMATELY 7 YEARS AFTER THE INITIAL FOR LOOSENING OF THE STEM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854531 SIRIUS HIP STEM 44-D PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 764530

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10 NARRATIVE