BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL GLENOID COMPONENT 46 MM ARTICULAR SURFACE

    MDR report key: 16022491 · Received December 21, 2022

    Report

    Report Number
    0001822565-2022-03533
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    November 29, 2022
    Report Date
    February 23, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K071090
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 ASSOCIATED PRODUCTS & MDRS. PRODUCT ID: 113610, COMP PRIMARY STEM ,10MM MICRO, LOT#: 115800, MDR: 0001825034-2022-02745. ITEM#118001; LOT# 139970 PRODUCT ID: 113032, VERSA-DIAL, 42X18X46 HUM HEAD, LOT#: 214780, MDR: 0001825034-2022-02748. ADDITIONAL ASSOCIATED PRODUCTS: PRODUCT ID: 118001, VERSA-DIAL/COMP TI STD TAPER.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.   NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS OR THE REPORTED PART AND LOT COMBINATION. X-RAY IMAGES WERE SENT TO MMI FOR REVIEW, WITH THE FOLLOWING NOTED: FIVE VIEWS OF THE LEFT SHOULDER DEMONSTRATE A LEFT TOTAL SHOULDER ARTHROPLASTY WITH FRACTURED GLENOID COMPONENT ALONG THE SUPERIOR ASPECT. SIGNIFICANT RADIOLUCENCY ALONG THE SUPERIOR GLENOID IS PRESENT. MULTIPLE LINEAR AND GLOBULAR HYPERDENSE FOCI ALONG THE JOINT CAPSULE SUGGESTS SYNOVITIS OR METALLOSIS. MEDICAL RECORDS WERE RECEIVED AND THE FOLLOWING WAS NOTED: SYNOVITIS WITH SYNOVECTOMY. FAILED LEFT TOTAL SHOULDER ARTHROPLASTY PERFORMED AT AN OUTSIDE FACILITY, WITH FRAGMENTING GLENOID, WITH LARGE UNCONTAINED POSTERIOR GLENOID DEFECT. - REMOVED THE GLENOID; HOWEVER, THERE WAS NO BACKSIDE, SO ALL THIS WAS JUST PRESERVING THE FRONT SIDE. EVENTUALLY WIGGLED IT OUT, AND THERE WAS A LARGE NON-CONTAINED DEFECT. - DEFECT IN THE GLENOID WAS SO LARGE, PERFORMING IT IN A SINGLE STAGE WOULD BE IMPOSSIBLE. THE COMPLAINT IS CONFIRMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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

    IT WAS REPORTED THAT A PATIENT IS SCHEDULED FOR A REVISION SURGERY SIX(6) YEARS POST IMPLANTATION DUE DISASSOCIATION AND PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT THE STAGE I OF A TWO STAGE REVISION DUE TO A LARGE, NON-CONTAINED, GLENOID DEFECT APPROXIMATELY 7 YEARS POST IMPLANTATION. DURING THE SURGERY, THE GLENOID WAS FOUND FRAGMENTING AND A SYNOVECTOMY WAS PERFORMED DUE TO SYNOVITIS. ALL COMPONENTS WERE REMOVED AND A SPACER WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465302 TRABECULAR METAL GLENOID COMPONENT 46 MM ARTICULAR SURFACE PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 62700439

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other SEE H10 NARRATIVE.