BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, ÿ 4X46MM

    MDR report key: 21875727 · Received April 21, 2025

    Report

    Report Number
    0009613350-2025-00328
    Event Type
    Injury
    Date Received
    April 21, 2025
    Date of Event
    June 30, 2023
    Report Date
    September 29, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505476
    PMA / PMN Number
    K231114
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT (B)(4). . NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. FOR REF 47248603840 DUE TO THE LACK OF THE LOT NUMBER, AN ADDITIONAL LOT SEARCH COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. IT WAS NOTED THAT THE SCREW LOOSENING/MIGRATION IS DUE TO OSTEOPOROSIS. HOWEVER, THERE ARE NO FURTHER DOCUMENTS AVAILABLE THAT COULD CONFIRM THIS. AS THE DEVICES INVOLVED IN THE REPORTED EVENT WERE NOT RETURNED FOR INVESTIGATION, A FURTHER PRODUCT EVALUATION COULD NOT BE PERFORMED AND THE CONDITION OF THE PRODUCTS ARE UNKNOWN. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL, AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREW. 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)(4). D4: PRODUCT ID WAS PROVIDED FOR TWO SCREWS HOWEVER, IT IS UNKNOWN WHICH OF THE TWO SCREWS HAS MIGRATED. THEREFORE, THE MIGRATED SCREW COULD BE ANY OF THE FOLLOWING: 47248604640 ¿ BLUNT TIP SCREW ¿ 3152738 UDI: (B)(4). MANUFACTURING DATE: MAR 27, 2023 EXPIRATION DATE: MAR 27, 2028 47248603840 ¿ BLUNT TIP SCREW ¿UNKNOWN UDI: UNKNOWN MANUFACTURING DATE: UNKNOWN. EXPIRATION DATE: UNKNOWN. . D10: ANTE/RETROGRADE HUMERUS, #ITEM 47249728009, #LOT 3031575 BLUNT TIP SCREW, # ITEM 47248603840, #LOT UNKNOWN ANTE/RETROGRADE HUMERUS NAIL CAP, #ITEM 47248800800, #LOT 3010698 CORTICAL BONE SCREW, # ITEM 47248612440, #LOT 3167005 . THERAPY DATE: (B)(6) 2023 G2: SWITZERLAND ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT AFTER A MONTH POST IMPLANTATION WENT FOR A REVISION SURGERY FOR THE REMOVAL OF A SCREW DUE TO MIGRATION BECAUSE OF OSTEOPOROSIS. THE SUBJECT IS REPORTED AS IMPROVED/RECUPERATED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016086 BLUNT TIP SCREW, ÿ 4X46MM IMPLANT, TRAUMA HSB ZIMMER GMBH 3152738 00889024505476

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Hospitalization| R SEE H11 NARRATIVE