BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X40 ST

    MDR report key: 20346750 · Received October 1, 2024

    Report

    Report Number
    0001825034-2024-02310
    Event Type
    Injury
    Date Received
    October 1, 2024
    Date of Event
    July 9, 2024
    Report Date
    March 27, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304677180
    PMA / PMN Number
    K130390
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2; H3; H6. H10: 0001825034-2024-02306-1, 0001825034-2024-02307-1, 0001825034-2024-02308-1, 0001825034-2024-02309-1. 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. FOLLOW UPS DETERMINED THAT THE PATIENT HAD POOR BONE QUALITY AT THE TIME OF LOOSENING, HOWEVER THE BONE QUALITY AT THE TIME OF IMPLANTATION REMAINS UNKNOWN. 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. D10: MEDICAL PRODUCTS: ITEM#: 110027734, COMPR VRS GLEN PPS MIN TPR ADR; LOT#: 66192751. ITEM#: 180551, COMP LK SCR 3.5HEX 4.75X20 ST; LOT#: 65699984. ITEM#: 180553, COMP LK SCR 3.5HEX 4.75X30 ST; LOT#: 65930511. ITEM#: 180554, COMP LK SCR 3.5HEX 4.75X35 ST; LOT#: 877630. ITEM#: 115400, COMP RVS CNTRL 6.5X50MM ST/RST; LOT#: 409840. H11: 0001825034-2024-02306, 0001825034-2024-02307, 0001825034-2024-02308, 0001825034-2024-02309. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCTS: ITEM#: 110027734, COMPR VRS GLEN PPS MIN TPR ADR; LOT#: UNKNOWN; ITEM#: 115400, COMP RVS CNTRL6.5X50MM ST/RST; LOT#: 409840; ITEM#: 180551, COMP LK SCR 3.5HEX 4.75X20 ST; LOT#: 65699984; ITEM#: 180553, COMP LK SCR 3.5HEX 4.75X30 ST; LOT#: 65930511; ITEM#: 180554, COMP LK SCR 3.5HEX 4.75X35 ST; LOT#: 877630. MULTIPLE SCREWS WERE REPORTED AS THE REPORTER WAS NOT SURE WHICH PERIPHERAL SCREWS ACTUALLY LOOSENED. G2: FOREIGN: JAPAN. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. 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

    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 SHOULDER ARTHROPLASTY WITH A VRS SYSTEM APPROXIMATELY ONE (1) YEAR AGO. THE PATIENT DEVELOPED A POSTOPERATIVE INFECTION APPROXIMATELY NINE (9) MONTHS LATER WHEN THE POLY LINEAR AND GLENOSPHERE HEAD WERE REPLACED. SUBSEQUENTLY, THE PATIENT UNDERWENT A SECOND REVISION SURGERY APPROXIMATELY A MONTH AND A HALF AGO DUE TO LOOSENING OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44216 COMP LK SCR 3.5HEX 4.75X40 ST SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 849670 00880304677180

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H