BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 20397814 · Received October 8, 2024

    Report

    Report Number
    0001825034-2024-02361
    Event Type
    Injury
    Date Received
    October 8, 2024
    Report Date
    December 12, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304532465
    PMA / PMN Number
    K193373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: MEDICAL PRODUCTS: ITEM#: 115397, COMP RVS CNTRL 6.5X35MM ST/RST; LOT#: 66082758, ITEM#: 180559, COMP NLK SCR 3.5HEX 4.75X25 ST; LOT#: 66127676, ITEM#: 180562, COMP NLK SCR 3.5HEX 4.75X40 ST; LOT#: 859790, ITEM#: 180561, COMP NLK SCR 3.5HEX 4.75X35 ST; LOT#: 66138820, ITEM#: 180559, COMP NLK SCR 3.5HEX 4.75X25 ST; LOT#: 66127676, ITEM#: 115316, COMP RVRS SHLDR GLNSP +6 36MM; LOT#: 135990, ITEM#: 00-4349-010-17, TM REVERSE STEM 10MM X 170MM; LOT#: 65550644, ITEM#: 00-4349-036-00, 36MM POLY LINER PLUS 0MM OFS; LOT#: 65871436. 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. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; D10; G2; G3; G6; H1; H2; H3; H6 D10: MEDICAL PRODUCTS: ITEM#: 180562, COMP (B)(4); LOT#: 919680 H10: RELATED REPORT NUMBERS: 0001825034-2024-02362-1. 0001825034-2024-02363-1. 0001825034-2024-02364-1. 0001825034-2024-02365-1. 0001825034-2024-02366-1. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: REVERSE TOTAL SHOULDER ARTHROPLASTY WITH FRACTURE GLENOID SCREWS BUT NO DISLOCATION. SIZING IS APPROPRIATE. THERE ARE MULTIPLE FRACTURED GLENOID SCREWS FROM A REVERSE TOTAL SHOULDER ARTHROPLASTY. IT WAS NOTED THAT 5 PERIPHERAL SCREWS WERE INVOICED PER USAGE AND STICKER SHEETS. THE BASEPLATE ONLY HAS OPENINGS FOR 4. HOWEVER, IT IS UNKNOWN WHICH ITEM WAS NOT IMPLANTED AND WHY IT WAS NOT USED. AS SUCH, 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

    CMP-0959064 D10: MEDICAL PRODUCTS: ITEM#: 115397, COMP RVS CNTRL 6.5X35MM ST/RST; LOT#: UNKNOWN. ITEM#: 180559, COMP NLK SCR 3.5HEX 4.75X25 ST; LOT#: UNKNOWN ITEM#: 180562, COMP NLK SCR 3.5HEX 4.75X40 ST; LOT#: UNKNOWN. ITEM#: 180561, COMP NLK SCR 3.5HEX 4.75X35 ST; LOT#: UNKNOWN . ITEM#: 180559, COMP NLK SCR 3.5HEX 4.75X25 ST; LOT#: UNKNOWN. ITEM#: 115316, COMP RVRS SHLDR GLNSP +6 36MM; LOT#: UNKNOWN. ITEM#: 00-4349-010-17, TM REVERSE STEM 10MM X 170MM; LOT#: UNKNOWN. ITEM#: 00-4349-036-00, 36MM POLY LINER PLUS 0MM OFS; LOT#: UNKNOWN. G2: FOREIGN: FRANCE. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED IN THE PATIENT. 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 NON-ZIMMER BIOMET PRODUCTS ON AND UNKNOWN DATE. THE PATIENT THEN UNDERWENT A REVISION SURGERY APPROXIMATELY ONE (1) YEAR AGO DUE TO AN UNKNOWN REASON. SUBSEQUENTLY, SEVERAL MONTHS AFTER THE REVISION SURGERY, THERE APPEARED TO BE LOOSENING OF THE GLENOID IMPLANTS. THE PATIENT WILL UNDERGO A REVISION SURGERY ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21584 COMP RVRS 25MM BSPLT HA+ADPTR SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 66053299 00880304532465

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SEE H11 NARRATIVE.| SEE H11 NARRATIVE.| SEE H11 NARRATIVE.