BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPR RVS GLENO 2-PRNG INS/IMP

    MDR report key: 17940278 · Received October 16, 2023

    Report

    Report Number
    0001825034-2023-02372
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    September 20, 2023
    Report Date
    January 12, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304731394
    PMA / PMN Number
    K193373
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE THE ASSOCIATED REPORT: 0001825034-2023-02373 D10: ITEM NUMBER: 110028879 LOT NUMBER: UNKNOWN E1: FULL ESTABLISHMENT NAME - THUNDER BAY REGIONAL HEALTH SCIENCES CENTRE G2: FOREIGN - THE EVENT OCCURRED IN CANADA THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT 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. D10: ITEM NUMBER: 110028879. LOT NUMBER: 250250. THE REPORTED EVENT IS CONFIRMED FOR 1 (ONE) IMPACTOR BUT NOT THE OTHER. ONLY 1 (ONE) FRACTURED PAD WAS RETURNED, AND THE PROVIDED PICTURE IS NOT CLEAR ENOUGH TO DETERMINE IF BOTH PADS BROKE. VISUAL EXAMINATION OF THE RETURNED PRODUCT/PROVIDED PICTURES IDENTIFIED BOTH ITEMS SHOW SIGNS OF USE WITH GOUGES ON THE STRIKE PLATE. LOT NUMBER 803760 ALSO HAS SOME DAMAGE TO ONE OF THE PRONGS. THERE WAS ALSO ONE PIECE OF THE BLACK POLY INSERTER END CAP RETURNED. UNABLE TO IDENTIFY WHICH INSERTER IT BELONGS. THE PICTURE PROVIDED SHOWED 2 (TWO) PADS, BUT IT WASN'T CLEAR IF BOTH WERE BROKEN. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A REVERSE SHOULDER ARTHROPLASTY PERFORMED APPROXIMATELY THREE (3) WEEKS AGO, TWO SEPARATE 2-PRONG GLENOSPHERE IMPACTOR/INSERTER HOLDERS FRACTURED WHEN ATTEMPTING TO BE IMPACTED INTO PLACE WITH A METAL MALLET. THE PROCEDURE WAS COMPLETED USING A THIRD GLENOSPHERE IMPLANT HOLDER. THE PATIENT RETAINED NO FOREIGN BODIES AND THERE WERE NO REPORTED CONSEQUENCES AS A RESULT OF THIS MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682878 COMPR RVS GLENO 2-PRNG INS/IMP SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 803760 00880304731394

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose