BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFIXUS HIP FRACTURE NAIL LAG SCREW 10.5MMX110MM

    MDR report key: 18924090 · Received March 18, 2024

    Report

    Report Number
    0001825034-2024-00746
    Event Type
    Injury
    Date Received
    March 18, 2024
    Report Date
    August 29, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    UDI-DI
    00887868039041
    PMA / PMN Number
    K100238
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCTS: ITEM#: 814501080, HFN A/R SCREW 80MM; LOT#: SP1122280F; ITEM#: 814503000, HFN END CAP FLUSH; LOT#: TD1113 B; ITEM#: 814511180; HFN 130 DEG 11MM X 180MM; LOT#: 748660. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTION WAS CORRECTED: HEALTH EFFECT - IMPACT CODE, DEVICE REVISION OR REPLACEMENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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. 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.

    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 THIS IS CAUSING THE PATIENT DISCOMFORT. THE SURGEON HAS RECOMMENDED THAT THE SCREW BE EXPLANTED FROM THE PATIENT. A REVISION SURGERY HAS NOT BEEN SCHEDULED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE HAS BEEN RECEIVED.

    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.

    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
    1018125 AFFIXUS HIP FRACTURE NAIL LAG SCREW 10.5MMX110MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES/TRAUMA HSB ZIMMER BIOMET, INC. TC1132310A 00887868039041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H10 NARRATIVE.