BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR VRS GLEN PPS MIN TPR ADR

    MDR report key: 13453325 · Received February 4, 2022

    Report

    Report Number
    0001825034-2022-00241
    Event Type
    Injury
    Date Received
    February 4, 2022
    Report Date
    March 18, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304818934
    PMA / PMN Number
    K202232
    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: 0001825034-2022-00242-1, 0001825034-2022-00243-1, 0001825034-2022-00244-1, 0001825034-2022-00245-1, 0001825034-2022-00246-1. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D4; G3; G6; H1; H2; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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: 0001825034-2022-00242, 0001825034-2022-00243, 0001825034-2022-00244, 0001825034-2022-00245, 0001825034-2022-00246. OUTCOMES ATTRIBUTED TO ADVERSE EVENT: PHX. MEDICAL PRODUCTS: 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. 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
    947339 COMPR VRS GLEN PPS MIN TPR ADR SHOULDER PROTHESIS/REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. N/A 298290 00880304818934

    Patients

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