BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIRIUS HIP STEM 44-D

    MDR report key: 8823591 · Received July 24, 2019

    Report

    Report Number
    0001825034-2019-03118
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    May 13, 2019
    Report Date
    June 24, 2021
    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
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING SEVERE OSTEOLYSIS IN DISTAL PART OF THE FEMUR SURROUNDING THE STEM. LARGE CYST UNDER THE FEMUR PROSTHESIS. THIN BONE WAS NOTED. THE RIGHT STEM ASEPTIC LOOSENING DUE TO SEVERE OSTEOLYSIS. ADDITIONAL INFORMATION DOES NOT CHANGE THE PREVIOUS INVESTIGATION RESULTS. 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

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. REVIEW OF THE MEDICAL RECORDS IDENTIFIED THAT THE PATIENT HAD A CYST AND FLUID ON THE HIP WITH OSTEOLYSIS, FOUND ON MRI IMAGING. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT PRESENTED TO PHYSICIAN APPROXIMATELY 5 YEARS POST INITIAL RIGHT HIP TOTAL ARTHROPLASTY WHERE OSTEOLYSIS WAS FOUND ALONG WITH FLUID AND CYST NEAR THE STEM. APPROXIMATELY 18 MONTHS LATER, IT WAS NOTED THAT THE OSTEOLYSIS HAD PROGRESSED AND THE STEM COMPONENT HAD BECOME LOOSE. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE LOOSE STEM. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-363662 36MM COCR MOD HD STD 642860; 131360 EXC ABT RNGLC-X SHELL PC 060MM 3241538; XL-053660 RLOC-X ARCOMXL H/W 60/36MM 26 32226888. REPORT SOURCE: FOREIGN SOURCE - (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED OSTEOLYSIS, FLUID, AND CYST APPROXIMATELY 5 YEARS POST INITIAL IMPLANTATION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615282 SIRIUS HIP STEM 44-D PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 173010

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| O| R