BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5X28MM CORT LOCK SCR STE

    MDR report key: 20693725 · Received November 15, 2024

    Report

    Report Number
    0001825034-2024-02697
    Event Type
    Injury
    Date Received
    November 15, 2024
    Date of Event
    October 22, 2024
    Report Date
    March 28, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    PMA / PMN Number
    K143697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4, B5, G1, G3, G6, H2, H6, H11. THE FOLLOWING SECTIONS HAVE BEEN CORRECTED: D4. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SINGLE AP VIEW OF THE LEFT SHOULDER DEMONSTRATES LATERAL PLATE AND SCREW FIXATION DEVICE OF THE PROXIMAL HUMERUS WITH MULTIPLE SCREWS. THERE IS A FRACTURED SCREW INFERIORLY WITH SEPARATION OF THE PLATE FROM THE HUMERAL DIAPHYSIS. LUCENCY SURROUNDS TWO OF THE REMAINING INTACT INFERIOR SCREWS. LOOSENING OF THE TWO INFERIOR MOST SCREWS NOW SEEN. THERE IS FRACTURED SCREW INFERIORLY AS WELL AS SEPARATION OF THE PLATE FROM THE HUMERAL DIAPHYSIS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS CONFIRMED. XRAYS WERE PROVIDED. D4: POSSIBLE LOT NUMBERS: BECAUSE IT WAS UNKNOWN WHICH LOT NUMBER WAS FRACTURED. THE FOLLOWING LOT NUMBERS ARE REPORTED: LOT # 66395007, 66421922 AND 61253414B. LOT 66395007. EXPIRE DATE: 2033-12-18. MANUFACTURE DATE: 2023-12-18. UDI: (B)(4). LOT 66421922, EXPIRE DATE: 2034-01-12, MANUFACTURE DATE: 2024-01-12. UDI: (B)(4). LOT 61253414B EXPIRE DATE: 2032-05-03 MANUFACTURE DATE: 2022-05-03 UDI: (B)(4). CATALOG #: 856135028, 3.5X28MM CORT LOCK SCR STE, LOT # 66395007, CATALOG #: 856135028, 3.5X28MM CORT LOCK SCR STE, LOT # 66421922, CATALOG #: 856135026, 3.5X26MM CORT LOCK SCR STE, LOT # 61253414B. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). UNKNOWN WHICH LOT NUMBER WAS FRACTURED: D4: 66395007 AND 66421922. D10 - MEDICAL PRODUCT: CATALOG #: 856135028, 3.5X28MM CORT LOCK SCR STE, LOT # 66395007. CATALOG #: 856135028, 3.5X28MM CORT LOCK SCR STE, LOT # 66421922. CATALOG #: 856135026, 3.5X26MM CORT LOCK SCR STE, LOT # 61253414B. G2: JAPAN. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). UPDATED: B4, B5, D2, D4, G3, H1, H2, H6, H11. D4: IT IS UNKNOWN WHICH LOT NUMBER WAS FRACTURED: LOT 66395007, EXPIRE DATE: 2033-12-18, MANUFACTURE DATE: 2023-12-18, UDI: (B)(4). LOT 66421922, EXPIRE DATE: 2034-01-12, MANUFACTURE DATE: 2024-01-12, UDI: (B)(4). 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

    NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROUTINE POSTOPERATIVE CHECKUP, X-RAYS REVEALED THAT ONE OF THE DISTAL SCREWS HAD FRACTURED OFF. IT WAS ALSO FOUND THAT THE OTHER TWO SCREWS WERE SLIGHTLY RETRACTED. BECAUSE THE PATIENT IS NOT COMPLAINING OF PAIN, THE SURGEON WILL KEEP AN EYE ON THE PATIENT CONDITION. NO FURTHER INTERVENTION IS PLANNED TO DATE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION 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
    1204585 3.5X28MM CORT LOCK SCR STE TRAUMA IMPLANT HRS ZIMMER BIOMET, INC. N/A SEE H11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male