BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X40 ST

    MDR report key: 19606507 · Received June 25, 2024

    Report

    Report Number
    0001825034-2024-01674
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    April 30, 2024
    Report Date
    October 31, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304677180
    PMA / PMN Number
    K132239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED AS VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE SCREWS, BASEPLATE, TAPER, GLENOSPHERE, AND BEARING HAVE BEEN EXPLANTED AND ARE COVERED IN BIODEBRIS. TWO PERIPHERAL SCREWS AND ONE CENTRAL SCREW HAVE FRACTURED. THE LINER APPEARS TO HAVE ABNORMAL WEAR AS A RESULT OF THE LOOSENING, BUT IT CANNOT BE CONFIRMED DUE TO THE BIODEBRIS REMNANTS ON THE ARTICULATING SURFACE. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: TWO VIEWS LEFT SHOULDER DEMONSTRATE A REVERSE TOTAL SHOULDER ARTHROPLASTY WITH FRACTURED GLENOSPHERE SCREWS WITH GLENOSPHERE DIRECTED SUPERIORLY. GLENOHUMERAL DISLOCATION. NO BONY FRACTURE SEEN. SIZING IS APPROPRIATE. BONY RESORPTION OF THE GLENOID IS SUSPECTED BUT POORLY SEEN AND MAY HAVE CONTRIBUTED TO THIS FAILURE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. IT WAS REPORTED THAT THE SURGEON ELECTED TO USE A BONE GRAFT DURING THE INITIAL PROCEDURE AND THE BONE GRAFT RESORBED; THEREFORE, THE BONE GRAFT IS A POSSIBLE CONTRIBUTING FACTOR TO THE REPORTED ISSUE. HOWEVER, WITH THE INFORMATION AVAILABLE 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

    (B)(4). THIS WAS PREVIOUSLY REPORTED UNDER 0001822565-2024-01745. IT IS KNOWN FROM THE X-RAY THAT 3 SCREWS FRACTURED OUT OF THE 5; HOWEVER, IT IS UNKNOWN WHICH OF THE 3 SCREWS FRACTURED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED BECAUSE THE PART/LOT INFORMATION COULD BE: CATALOG #: 180560, COMP NLKSCR 3.5HEX 4.75X30 ST, LOT #976370. CATALOG #: 180560, COMP NLK SCR 3.5HEX 4.75X30 ST, LOT #979490. CATALOG #: 180555, COMP LK SCR 3.5HEX 4.75X40 ST, LOT # 017930. CATALOG #: 115396, COMP RVS CNTRL 6.5X30MM ST/RST, LOT # 017690. CATALOG #: 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT # 533810. D10 - MEDICAL PRODUCT: CATALOG #: 180560, COMP NLKSCR 3.5HEX 4.75X30 ST, LOT #976370. CATALOG #: 180560, COMP NLK SCR 3.5HEX 4.75X30 ST, LOT #979490. CATALOG #: 180555, COMP LK SCR 3.5HEX 4.75X40 ST, LOT # 017930. CATALOG #: 115396, COMP RVS CNTRL 6.5X30MM ST/RST, LOT # 017690. CATALOG #: 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT # 533810. CATALOG #: 115330, COMP RVRS SHDR GLEN BSPLT +HA, LOT # 247470. CATALOG #: 00434904006, 40MM ÿ +6MM OFFSET POLY LINER, LOT # 62438566. CATALOG #: 110030776, STANDARD OFFSET 40MM DIAMETER GLENOSPHERE, LOT # 65026824. G2: AUSTRALIA. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS REQUESTED BUT NOT RETURNED TO THE HOSPITAL. 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

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOSS OF FIXATION DUE TO BONE GRAFT RESORPTION, SCREW BREAKAGE, INSTABILITY, AND PAIN. THE GLENOSPHERE AND BASEPLATE WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697821 COMP LK SCR 3.5HEX 4.75X40 ST EXTREMITY IMPLANT KWS ZIMMER BIOMET, INC. N/A 017930 00880304677180

    Patients

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