BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS CNTRL 6.5X40MM ST/RST

    MDR report key: 16410308 · Received February 21, 2023

    Report

    Report Number
    0001825034-2023-00360
    Event Type
    Injury
    Date Received
    February 21, 2023
    Date of Event
    January 23, 2023
    Report Date
    July 11, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304677104
    PMA / PMN Number
    K193373
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. ONLY THE STEINMANN PIN CONTAINS NICKEL, WHICH IS THE CONFIRMED METAL ALLERGY ALLEGATION. THIS PRODUCT IS CONFIRMED TO NOT CONTAIN NICKEL; THEREFORE, THE INITIAL REPORT SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCT: CATALOG #: 405800, COMP. REV SHLDR 9 IN STEINMANN, LOT # 130520. CATALOG #: 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT # 886240. CATALOG #: 180550, COMP LK SCR 3.5HEX 4.75X15 ST, LOT # 437540. CATALOG #: 180550, COMP LK SCR 3.5HEX 4.75X15 ST, LOT # 098780. CATALOG #: 180551, COMP LK SCR 3.5HEX 4.75X20 ST, LOT # 918800. CATALOG #: 180551, COMP LK SCR 3.5HEX 4.75X20 ST, LOT # 855910. CATALOG #: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, LOT # 656600. CATALOG #: 113611, COMP PRIMARY STEM 11MM MICRO, LOT # 65319533. CATALOG #: 110031424, CR VIVACIT-E 36MM BRNG STD, LOT # 65434165. CATALOG #: 110031399, MINI TRAY STD COCR +0 OFFSET, LOT # 65398274. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS BEEN REQUESTED BUT NOT RETURNED BY HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-00354, 0001825034-2023-00355, 0001825034-2023-00356, 0001825034-2023-00357, 0001825034-2023-00358, 0001825034-2023-00359, 0001825034-2023-00361, 0001825034-2023-00362, 0001822565-2023-00438, AND 0001822565-2023-00439.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. ONLY THE STEINMANN PIN CONTAINS NICKEL, WHICH IS THE CONFIRMED METAL ALLERGY ALLEGATION. THIS PRODUCT IS CONFIRMED TO NOT CONTAIN NICKEL; THEREFORE, THE INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY 3 MONTHS POST IMPLANTATION DUE TO AN SUSPECTED NICKEL ALLERGY. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407371 COMP RVS CNTRL 6.5X40MM ST/RST EXTREMITY IMPLANTS KWS ZIMMER BIOMET, INC. N/A 655670 00880304677104

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H