BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HFN 130 DEG 11MM X 180MM

    MDR report key: 19070992 · Received April 9, 2024

    Report

    Report Number
    0001825034-2024-00974
    Event Type
    Injury
    Date Received
    April 9, 2024
    Report Date
    August 29, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    UDI-DI
    00887868039102
    PMA / PMN Number
    K100238
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(6). D10: MEDICAL COMPONENTS: ITEM#: 814510110, HFN LAG SCREW 10.5MM X 110MM; LOT#: TC1132310A. ITEM#: 814501080, HFN A/R SCREW 80MM; LOT#: SP1122280F. ITEM#: 814503000, HFN END CAP FLUSH; LOT#: TD1113 B. G2: FOREIGN: POLAND. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP FRACTURE SURGERY APPROXIMATELY SEVEN (7) YEARS AGO, SUBSEQUENTLY, THE PATIENT IS ABLE TO PALPATE THE LAG SCREW THROUGH THE SKIN AND WAS CAUSING THE PATIENT DISCOMFORT. THE PATIENT UNDERWENT A REVISION SURGERY ON AND UNKNOWN DATE AND ALL IMPLANTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541055 HFN 130 DEG 11MM X 180MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER BIOMET, INC. 748660 00887868039102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE.