BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIRIUS HIP STEM

    MDR report key: 7321190 · Received March 7, 2018

    Report

    Report Number
    0001825034-2018-01734
    Event Type
    Injury
    Date Received
    March 7, 2018
    Date of Event
    January 10, 2017
    Report Date
    June 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDG
    PMA / PMN Number
    PK130610
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. X-RAY REVIEW BY RADIOLOGIST NOTES EVIDENCE OF MINIMAL ENTHESOPATHIC CHANGE AT THE GREATER TROCHANTER ON ALL SUBMITTED IMAGES, MOST LIKELY SECONDARY TO GLUTEUS MEDIUS TENDINOSIS. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. 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 · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MEDICAL DEVICES: ITEM #: 163668, ITEM NAME: COCR FEMORAL HEAD, LOT #: 0000716267, ITEM #: 131352, ITEM NAME: RINGLOC ACETABULAR SHELL , LOT #: 2902081, ITEM #: XL-053252, ITEM NAME: RINGLOC-X ARCOM LINER, LOT #: 3306130, ITEM #: 66017569, ITEM NAME: PALACOS BONE CEMENT, LOT #: 78804375. COMPLAINT WAS REPORTED FROM (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01731.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS EXPERIENCING PAIN AND TROCHANTER BURSITIS APPROXIMATELY TWO YEARS POST-IMPLANTATION REQUIRING A STEROID INJECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164843 SIRIUS HIP STEM PROSTHESIS, HIP JDG ZIMMER BIOMET, INC. N/A 770833

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention