BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP PRIMARY STEM 11MM MINI

    MDR report key: 10786546 · Received November 4, 2020

    Report

    Report Number
    0001825034-2020-03919
    Event Type
    Injury
    Date Received
    November 4, 2020
    Date of Event
    October 22, 2020
    Report Date
    January 20, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304462687
    PMA / PMN Number
    K060692
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED ITEM AND LOT INFORMATION FOR THE DEVICES IN QUESTION. THE TAPER AND HEAD WERE COVERED WITH BLOOD LIKELY FROM REMOVAL. THE STEM HAD BIOLOGICAL DEBRIS AND BLOOD ON THE POROUS COATING. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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. ZIMMERBIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    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: ITEM# 113032; LOT# 922330; VERSA-DIAL 42X18X46 HUM HEAD. ITEM# 118001; LOT# 137900; VERSA-DIAL/COMP TI STD TAPER. FOREIGN REPORT SOURCE: (B)(6). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-03918.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HEMI-ARTHROPLASTY AROUND 2-3 YEARS AGO. SUBSEQUENTLY, PATIENT WAS REVISED DUE TO SHOULDER PAIN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248148 COMP PRIMARY STEM 11MM MINI EXTREMITIES, IMPLANT KWS ZIMMER BIOMET, INC. N/A 733410 00880304462687

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R