BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB®, CORTICAL SCREW, 5.0 MM, 38 MM

    MDR report key: 20174140 · Received September 9, 2024

    Report

    Report Number
    0009613350-2024-00441
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    August 9, 2024
    Report Date
    January 16, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    UDI-DI
    00889024291010
    PMA / PMN Number
    K192217
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4. PRODUCT ID WAS PROVIDED FOR TWO SCREWS HOWEVER, IT IS UNKNOWN WHICH OF THE TWO SCREWS WAS DISLODGED. THEREFORE, THE DISLODGED SCREW COULD BE ANY OF THE FOLLOWING: 0202150038 ¿ NCB CORTICAL SCREW ¿ 3109018. UDI: (B)(4). MANUFACTURING DATE: MAY 03, 2022. EXPIRATION DATE: MAY 03, 2027. 0202150038 ¿ NCB CORTICAL SCREW ¿ 3105058 (2). UDI: (B)(4). MANUFACTURING DATE: APR 10, 2022. EXPIRATION DATE: APR 10, 2027. D10. NCB®, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 12 HOLES, 278 MM ITEM# 0202264012 LOT# 3108787. NCB®, CORTICAL SCREW, 5.0 MM, 38 MM ITEM# 0202150038, LOT# 3105058, QTY: 2. G2. REPORT SOURCE: JAPAN. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED; THEREFORE, NO DIMENSIONAL ANALYSIS CAN BE PERFORMED. SOME PICTURES WERE PROVIDED. THE HEAD OF THE SCREWS SHOWS SIGNS OF WEAR AND POSSIBLE DEFORMATION. HOWEVER, DUE TO LACK OF PRODUCT IT IS NOT POSSIBLE TO DETERMINE THE EXTENT TO WHICH THE COMBINED WEAR ON THE SCREW HEAD AND SCREW HOLE CONTRIBUTED TO THE DISSOCIATION SITUATION THAT ULTIMATELY LED TO THE REVISION SURGERY. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORIES FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THESE ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. THE IMAGING OF THE RIGHT FEMUR SHOWS LATERAL PLATE AND SCREW FIXATION INVOLVING THE MID AND DISTAL DIAPHYSIS, EXTENDING INTO THE LATERAL FEMORAL CONDYLE. THERE IS AN OBLIQUE FRACTURE IN THE DISTAL DIAPHYSIS WITH POSSIBLE LOOSENING OF THE FIFTH AND SIXTH DISTAL SCREWS, DISLODGMENT OF THE SECOND SCREW, AND PARTIAL WITHDRAWAL OF THE FIRST SCREW. THE OVERALL FIT AND ALIGNMENT ARE APPROPRIATE IN THE SECOND IMAGE, BUT THE FIRST IMAGE INDICATES LOOSENING OF THE HARDWARE. SIGNS OF ISSUES INCLUDE THE DISLODGED SECOND SCREW, POTENTIAL LOOSENING OF THE FIFTH AND SIXTH SCREWS, AND PARTIAL WITHDRAWAL OF THE FIRST SCREW. THE BONE SHOWS PARTIAL HEALING OF THE OBLIQUE FRACTURE, WITH A LOOSENED FRACTURE LINE STILL VISIBLE DISTALLY AND MEDIALLY. NO OTHER ANATOMICAL FACTORS ARE EVIDENT THAT WOULD CONTRIBUTE TO THE NEED FOR REVISION. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. 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 OPERATION WAS PERFORMED WITH NCB PP PLATE SYSTEM. THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 21 MONTHS POST IMPLANTATION DUE TO ONE OF THE SCREWS PLACED IN THE METAPHYSEAL REGION BEING DISLODGED FROM THE BONE DUE TO A PSEUDOARTHROSIS. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601548 NCB®, CORTICAL SCREW, 5.0 MM, 38 MM IMPLANT, TRAUMA HRS ZIMMER GMBH N/A 3109018 00889024291010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE.