BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP +6 41MM

    MDR report key: 9126017 · Received September 26, 2019

    Report

    Report Number
    0001825034-2019-04333
    Event Type
    Injury
    Date Received
    September 26, 2019
    Date of Event
    February 21, 2019
    Report Date
    January 29, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 118001, VERSA-DIAL/COMP TI STD TAPER, LOT # 001810, CATALOG #: 115330, COMP RVRS SHDR GLEN BSPLT +HA, LOT # 524140. REPORTED EVENT WAS CONSIDERED CONFIRMED AS THE MEDICAL RECORDS AND X-RAYS NOTE SCAPULAR NOTCHING. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-00439 AND 0001825034-2020-00440.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). (UDI): N/A. MEDICAL PRODUCT: CATALOG #: UNKNOWN, COMPREHENSIVE 41 MM HUMERAL TRAY STANDARD, LOT # UNKNOWN, CATALOG #: UNKNOWN, COMPREHENSIVE STEM 11 MM CEMENTED; LOT # UNKNOWN, CATALOG #: UNKNOWN, COMPREHENSIVE HUMERAL BEARING; LOT # UNKNOWN, 115330 COMP RVRS SHDR GLEN BSPLT +HA 524140, 115383 COMP RVS CNTRL SCR 6.5X35MM ST 345360, 180505 COMP LOCKING SCREW 4.75X40MM 468620, 180502 COMP LOCKING SCREW 4.75X25MM 015250, 180502 COMP LOCKING SCREW 4.75X25MM 633670, 180506 COMP LOCKING SCREW 4.75X45MM 029390. 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. 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. REMAINS IMPLANTED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY PERFORMED APPROXIMATELY NINE (9) YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED ABOUT A YEAR AGO DUE TO HUMERAL TRAY FRACTURE FROM A TRAUMATIC EVENT WITH SECONDARY PAIN AND DISLOCATION. THE PATIENT CONTINUED PHYSICAL THERAPY AND HOME EXERCISES POST-REVISION WITH SATISFACTORY PROGRESS AND PAIN MANAGEMENT. INCIDENTALLY, SCAPULAR NOTCHING WAS NOTED ON THE SIX (6) MONTH POST-REVISION X-RAYS. NO INTERVENTION PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920404 COMP RVRS SHLDR GLNSP +6 41MM PROSTHESIS SHOULDER KWS ZIMMER BIOMET, INC. N/A 213380

    Patients

    Seq Age Sex Outcome Treatment
    1 Other