BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBULA COMP LOCK PLATE 8H STE

    MDR report key: 11772249 · Received May 4, 2021

    Report

    Report Number
    0001825034-2021-01363
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    April 7, 2021
    Report Date
    July 19, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    PMA / PMN Number
    K111663
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: TIBIAL NAIL 12.0MM X 300MM CAT: 40930 LOT: 286300; 3.5X14MM LOW PRO CORT SCR STE CAT: 851235014 LOT: 199400; 3.5X14MM LOW PRO CORT SCR STE CAT: 851235014 LOT: 979670; 3.5X10MM CORT LOCK SCR STE CAT: 856135010 LOT: 485430; 3.5X12MM CORT LOCK SCR STE CAT: 856135012 LOT: 486790; 3.5X12MM CORT LOCK SCR STE CAT: 856135012 LOT: 486960; 3.5X14MM CORT LOCK SCR STE CAT: 856135014 LOT: 716290; OFFSET END CAP 11X10MM CAT: 14-441282 LOT: 625640; TI-DBLE LEAD CORT 5.0X32MM SCR CAT: 14-405032 LOT: 497210; TI-DBLE LEAD CORT 5.0X34MM SCR CAT: 14-405034 LOT: 656950; TI-DBLE LEAD CORT 5.0X36MM SCR CAT: 14-405036 LOT: 220160; TI-DBLE LEAD CORT 5.0X38MM SCR CAT: 14-405038 LOT: 682280; TI-DBLE LEAD CORT 5.0X42MM SCR CAT: 14-405042 LOT: 483550. FOREIGN: (B)(6). IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE IMPLANTS. IT WAS INDICATED THAT THE PATIENT WILL BE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669637 FIBULA COMP LOCK PLATE 8H STE PLATE, FIXATION HRS ZIMMER BIOMET, INC. 489020

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other SEE H10