BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LAG SCREW

    MDR report key: 14869558 · Received June 30, 2022

    Report

    Report Number
    0009613350-2022-00355
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    October 14, 2021
    Report Date
    September 15, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CMN FEMORAL NAIL, CCD 130A, RIGHT, 11.5 MM, 38 CM ITEM# 47-2493-382-11 LOT# 2820901. REPORT SOURCE: (B)(6). INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350 - 2022 - 00354, 0009613350 - 2022 - 00355.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. A CORRECTION HAS BEEN MADE TO THE BRAND NAME OF THE SUSPECTED MEDICAL DEVICE AS WE PREVIOUSLY REPORTED AN IRRELEVANT INSTRUMENT IN ERROR. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D1, D2, D4, D6A, G3, G4, G6, H1, H2, H6, H10. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED, THEREFORE NO DEVICE HISTORY RECORD COULD BE REVIEWED. DEVICES ARE USED FOR TREATMENT. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO BE REVISED FOR ABLATION OF RIGHT FEMORAL CENTROMEDULLARY MATERIAL DUE TO INDICATIONS OF DISCOMFORT APPROXIMATELY 2.5 YEARS AFTER THE IMPLANTATION. DURING REMOVAL OF THE CEPHALIC SCREW, FRACTURE OF THE WINGS OCCURRED MAKING THE REMOVAL IMPOSSIBLE, WHICH RESULTED IN LEAVING THE NAIL AND THE CEPHALIC SCREW IN PLACE. THE REVISION SURGERY WAS RESCHEDULED. NO FURTHER PATIENT OUTCOME PROVIDED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A FEMORAL NAIL AND SCREW. AROUND 2.5 YEARS LATER, THE BONE HAD CONSOLIDATED AND THE PATIENT WAS FEELING DISCOMFORT SO A REVISION SURGERY TOOK PLACE. DURING THIS REVISION SURGERY, WHILE REMOVING THE LAG SCREW, FRACTURE OF THE WINGS MADE THE REMOVAL OF BOTH IMPLANTS IMPOSSIBLE. THE REVISION SURGERY HAD TO BE RESCHEDULED. THE SECOND REVISION SURGERY TOOK PLACE 49 DAYS LATER, IN THIS SURGERY THE SCREW AND NAIL WERE REMOVED WITHOUT DIFFICULTY (REPORTED UNDER 0009613350-2022-00353).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875060 UNKNOWN LAG SCREW HIP INTERNAL FIXATION SYSTEM HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R SEE H10 NARRATIVE