BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LOCKING SCREW

    MDR report key: 13453343 · Received February 4, 2022

    Report

    Report Number
    0001825034-2022-00246
    Event Type
    Injury
    Date Received
    February 4, 2022
    Report Date
    March 18, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: 0001825034-2022-00241-1, 0001825034-2022-00242-1, 0001825034-2022-00243-1, 0001825034-2022-00244-1, 0001825034-2022-00245-1. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-00241, 0001825034-2022-00242, 0001825034-2022-00243, 0001825034-2022-00244, 0001825034-2022-00245. MEDICAL PRODUCTS: ITEM#: 110027734, COMPR VRS GLEN PPS MIN TPR ADR; LOT#: 298290; ITEM#: UNKNOWN, UNKNOWN CENTRAL SCREW; LOT#: UNKNOWN; ITEM#: UNKNOWN, UNKNOWN LOCKING SCREW; LOT#: UNKNOWN; ITEM#: UNKNOWN, UNKNOWN LOCKING SCREW; LOT#: UNKNOWN; ITEM#: UNKNOWN, UNKNOWN LOCKING SCREW; LOT#: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE LOCATION OF THE PRODUCT IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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 A PATIENT UNDERWENT A FIRST STAGE REVISION OF A RIGHT SHOULDER PROSTHESIS APPROXIMATELY FOUR WEEKS POST IMPLANTATION DUE TO INSUFFICIENT FIXATION OF THE GLENOID COMPONENTS. THE PATIENT WAS IMPLANTED WITH A HEMIARTHROPLASTY AND CEMENT SPACERS UNTIL A CUSTOM GLENOID COMPONENT IS AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947342 UNKNOWN LOCKING SCREW SHOULDER PROSTHESIS/EXTREMITIES PHX ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization