BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPACTOR

    MDR report key: 12689030 · Received October 25, 2021

    Report

    Report Number
    0001825034-2021-02912
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    September 28, 2021
    Report Date
    November 5, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCTS: ITEM#: 00-5049-035-01, COMPACT VACUUM CEMENT MIXING SYSTEM; LOT#: 65058741. ITEM#: 405883, UNKNOWN GLENOID; LOT#: 180520. ITEM#: 405889, COMP RVS 2.7MM DIA DRL; LOT#: 062440. ITEM#: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR; LOT#: 228850. ITEM#: 113625, COMP PRIMARY STEM 5MM MINI; LOT#: 944390. ITEM#: TI-115313, COMP VRSDL GLNSPR 36MM +3 TI; LOT#: 354850. ITEM#: 115396, COMP RVS CNTRL 6.5X30MM ST/RST; LOT#: 499050. ITEM#: 180550, COMP LK SCR 3.5HEX 4.75X15 ST; LOT#: 971460. ITEM#: 180552, COMP LK SCR 3.5HEX 4.75X25 ST; LOT#: 336850. ITEM#: 180550, COMP LK SCR 3.5HEX 4.75X15 ST; LOT#: 821210. ITEM#: 180551, COMP LK SCR 3.5HEX 4.75X20 ST; LOT#: 464670. ITEM#: 110031413, HMRL TRAY +3 +10 TI; LOT#: 64352534. ITEM#: 110031424, HMRL BEARING 36 MM STD VITE; LOT#: 64980822. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4) THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G3; G6; H1; H2; H6 VISUAL EXAMINATION OF THE PROVIDED PICTURE IDENTIFIED THAT THE TIP OF THE IMPACTOR IS BROKE. PART AND LOT NUMBERS COULD NOT BE IDENTIFIED. 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 · 0

    IT WAS REPORTED THAT WHILE PHYSICIAN WAS USING THE INSTRUMENT TO IMPACT IMPLANT THE INSTRUMENT FRACTURED. THERE WAS NO IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585064 UNKNOWN IMPACTOR INSTRUMENT/EXTREMITIES HWA ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female