BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HUMERAL BEARING

    MDR report key: 12154616 · Received July 12, 2021

    Report

    Report Number
    0001825034-2021-02039
    Event Type
    Injury
    Date Received
    July 12, 2021
    Date of Event
    September 30, 2019
    Report Date
    May 31, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED/ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02038-3, 0001825034-2021-02040-3. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED AS IT WAS REPORTED ON THE INCORRECT MDRF NUMBER, 0001825034-2021-02039-3. THE PRODUCT HAS BEEN FOUND TO BE NOT REPORTABLE.

    Additional Manufacturer Narrative · 0

    CMP-(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02038-2 0001825034-2021-02040-2 INVESTIGATION REMAINS UNCHANGED FROM THE PREVIOUS INVESTIGATION. ADDITIONAL LEGAL RECORDS WERE PROVIDED, HOWEVER, THE COMPLAINT CATEGORIES AND HARMS WERE ALREADY ACCOUNTED FOR PREVIOUSLY. 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) THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02038-1 0001825034-2021-02040-1 THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; B6; G3; G6; H1; H2 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

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DURING I&D CULTURES PROCEDURE REVEALED THAT THE PATIENT WAS POSITIVE FOR ENTEROCOCUSS, FAECALIS, AND STAPHYLOCOCCUS EPIDERMIDIS SPECIES OF UNKNOWN SIGNIFICANCE. SUBSEQUENTLY, THE CARE OF THE PATIENT WAS TRANSFERRED TO AN INFECTIOUS DISEASE SPECIALIST APPROXIMATELY FOUR (4) WEEKS AFTER REVISION SURGERY. THE PATIENT WAS ALSO DIAGNOSED WITH A PROTHESIS JOINT INFECTION AT THAT TIME. THE PATIENT WAS UNDER THIS PHYSICIANS CARE FOR APPROXIMATELY ONE (1) YEAR AFTER THE REVISION SURGERY. THE PATIENT CONTINUES TO HAVE PAIN, DISCOMFORT AND LIMITED USE OF SHOULDER.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02038, 0001825034-2021-02040. MEDICAL PRODUCTS: ITEM#: UNKNOWN, UNKNOWN GLENOSPHERE; LOT#: UNKNOWN; ITEM#: UNKNOWN, UNKNOWN HUMERAL STEM; LOT#: UNKNOWN. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY EIGHTEEN (18) YEARS AGO FOR UNKNOWN REASON. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY TWO (2) YEARS AGO DUE TO PROXIMAL HUMOROUS FRACTURE. THE PATIENT UNDERWENT A SECOND REVISION APPROXIMATELY THREE (3) MONTHS AFTER FIRST REVISION DUE TO PROSTHESIS SUBLUXATION AND TUBEROSITY FRACTURE OF THEIR HUMERAL HEAD. APPROXIMATELY A MONTH AFTER SECOND REVISION THE PATIENT'S SHOULDER WAS INFECTED AND ANOTHER SURGICAL PROCEDURE WAS PERFORMED FOR THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052745 UNKNOWN HUMERAL BEARING SHOULDER PROSTHESIS/EXTREMITIES KWS ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10 NARRATIVE