BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 95 MM

    MDR report key: 19701990 · Received July 9, 2024

    Report

    Report Number
    0009613350-2024-00285
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    June 4, 2024
    Report Date
    November 12, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024298446
    PMA / PMN Number
    K192312
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D10; G3; H2; H3; H6. D10: ITEM # 00-2490-003-51 LOT #62859637 LONG CM LAG SCRW RETAIN SHAFT. ITEM # 00-2490-003-50 LOT #64495544 LONG CM LAG SCREW INSERTER. ITEM # 47-2493-381-11 LOT #3134388 Z NAIL CPM 11.5MM X 38CM 125 L. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: UNKNOW ITEM #, UNKNOW ZNN LONG TROCHANTERIC NAIL, LOT #: UNKNOWN. G2: REPORT SOURCE FRANCE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IT WAS NOTED DURING A REVISION THAT AFTER THE LOCKING SCREW REMOVAL, WE WERE UNABLE TO REMOVE THE HEAD SCREW FROM THE NAIL AND CONSEQUENTLY THE NAIL ITSELF. THE SCREWDRIVER COULD NOT, IN ANY CASE AND AFTER SEVERAL ATTEMPTS, BE FIXED ON THE CEPHALIC SCREW IN PLACE. THE SURGEON HAD A GOOD VISION OF THE SCREW AND IT HAD BEEN CLEARED OF ANY BONY ELEMENTS THAT COULD INTERFERE BETWEEN THE SCREW AND THE SCREWDRIVER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT HAS NOT YET BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499032 ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 95 MM PROSTHESIS, HIP HSB ZIMMER GMBH N/A 3140285 00889024298446

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other SEE H11 NARRATIVE| SEE H11 NARRATIVE