BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB®, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 15 HOLES, 317 MM

    MDR report key: 19480224 · Received June 6, 2024

    Report

    Report Number
    0009613350-2024-00219
    Event Type
    Injury
    Date Received
    June 6, 2024
    Date of Event
    May 13, 2024
    Report Date
    August 16, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    UDI-DI
    00889024292857
    PMA / PMN Number
    K100111
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: REPORT SOURCE AUSTRALIA. 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

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: ITEM # 02.02151.020, NCB UNICORTICAL SCR 5.0 L=20MM, LOT # 65047445. ITEM # 02.02150.300, NCB CLAMP-SCREW, LOT # 3147776. ITEM # 02.02150.300, NCB CLAMP-SCREW, LOT # 3146305. ITEM # 02.02150.300, NCB CLAMP-SCREW, LOT # 3127011. ITEM # 02.02150.300, NCB CLAMP-SCREW, LOT # 3035014. ITEM # 02.02150.075, NCB SCREW 5.0 L = 75, LOT # 3119443. ITEM # 02.02150.070, NCB SCREW 5.0 L = 70, LOT # 3121435. ITEM # 02.02150.060, NCB SCREW 5.0 L = 60, LOT # 3113051. ITEM # 02.02150.055, NCB SCREW 5.0 L = 55, LOT # 3109021. ITEM # 02.02150.050, NCB SCREW 5.0 L = 50, LOT # 3131981. ITEM # 02.02150.050, NCB SCREW 5.0 L = 50, LOT # 3034082. ITEM # 02.02150.036, NCB SCREW 5.0 L = 36, LOT # 3140498. ITEM # 02.02150.036, NCB SCREW 5.0 L = 36, LOT # 3136641. ITEM # 02.02150.032, NCB SCREW 5.0 L = 32, LOT # 3119547. ITEM # 02.02150.026, NCB SCREW 5.0 L = 26, LOT # 3153017. ITEM # 02.02150.060, NCB SCREW 5.0 L = 60, LOT # 3113051. NO PRODUCT WAS RETURNED FOR INVESTIGATION, HOWEVER PICTURES OF THE EXPLANTED PLATE, SCREWS AND CAP WERE PROVIDED. THE EVENT CAN BE CONFIRMED AS THE PLATE IS FRACTURED. NEVERTHELESS, DUE TO THE POOR QUALITY OF THE PICTURES, A DEEPER ASSESSMENT IS NOT POSSIBLE. 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. THE IMAGING INCLUDES 2 AP AND 2 CROSS-TABLE LATERAL VIEWS OF THE RIGHT FEMUR. THE EVALUATION OF THE RIGHT HIP ARTHROPLASTY IS LIMITED, BUT THE ALIGNMENT IS MAINTAINED. A FRACTURE IS OBSERVED IN THE FEMORAL FIXATION PLATE WITH SLIGHT DISPLACEMENT AT THE FRACTURE SITE, THOUGH THE CERCLAGE WIRES REMAIN INTACT. MULTIPLE INTRAOSSEOUS SCREWS ARE PRESENT BELOW THE PLATE, BUT THEY ARE NOT CONTIGUOUS WITH IT. REPARATIVE BONE FORMATION IS NOTED AT THE SITE OF THE PLATE FRACTURE. IN TERMS OF THE OVERALL FIT AND ALIGNMENT OF THE IMPLANTS, THERE IS NO DEFINITE LOOSENING, BUT THERE IS SLIGHT MALALIGNMENT AT THE FRACTURE SITE. THE BONE QUALITY IS MARKEDLY OSTEOPENIC. 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 PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY 5 MONTHS POST-IMPLANTATION DUE TO NCB®, PERIPROSTHETIC FEMUR PLATE BROKEN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6196 NCB®, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 15 HOLES, 317 MM PROSTHESIS, HIP HRS ZIMMER GMBH N/A 3124686 00889024292857

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention| H SEE H11 NARRATIVE.| UNKNOWN CAPS.| UNKNOWN SCREWS.