BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIRIUS HIP STEM 38-E

    MDR report key: 18182485 · Received November 21, 2023

    Report

    Report Number
    0001825034-2023-02702
    Event Type
    Injury
    Date Received
    November 21, 2023
    Date of Event
    October 23, 2023
    Report Date
    February 14, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K130610
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. UNABLE TO CONFIRM COMPLAINT. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: IMMEDIATE POST-OP- LEFT HIP ARTHROPLASTY IS ANATOMICALLY ALIGNED WITHOUT FRACTURE OR OTHER ABNORMALITY. 6 MONTHS POST-OP- ALIGNMENT IS ANATOMIC AND UNCHANGED. THERE IS NO FRACTURE. 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

    (B)(4). D10: 4341 ITEM NAME DISTAL PLUG PE 11MM LOT # 0000932909; 650-0660, ITEM NAME DELTA CERAMIC FEM HD 36/- 3MM LOT # 2015041477; 131352 ITEM NAME EXC ABT RNGLC-X SHELL PC 052MM LOT # 3648985; EP-083652 ITEM NAME RINGLOC-X E1 H/W +3MM 52/36MM LOT # 3464161; 66017569 ITEM NAME PALACOS CEMENT LOT # 81894448. G2: FOREIGN: DENMARK. 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 H3 OTHER TEXT : DEVICE LOCATION IS UNKNOWN.

    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 APPROXIMATELY 8 YEARS POST IMPLANTATION DUE TO FEMORAL PERI-PROSTHETIC FRACTURE THAT CAUSED PAIN. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1993450 SIRIUS HIP STEM 38-E PROSTHETIC, HIP JDI ZIMMER BIOMET, INC. N/A 712680

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention| H PLEASE SEE H10