BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE

    MDR report key: 8560320 · Received April 29, 2019

    Report

    Report Number
    0001825034-2019-01776
    Event Type
    Injury
    Date Received
    April 29, 2019
    Date of Event
    June 27, 2019
    Report Date
    September 16, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K080642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF INFORMATION RECEIVED AND REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE WAS NOT RELATED TO THE EVENT.

    Additional Manufacturer Narrative · 0

    PRODUCT CODE - PHX. CONCOMITANT MEDICAL PRODUCTS: COMP RVRS 25MM BSPLT HA+ADPTR CATALOG # 010000589 LOT # 193550 COMP RVS CNTRL 6.5X45MM ST/RST CATALOG # 115399 LOT # 57347 COMP LK SCR 3.5HEX 4.75X35 ST CATALOG # 180554 LOT # 700070 COMP LK SCR 3.5HEX 4.75X35 ST CATALOG # 180554 LOT # 466990 COMP LK SCR 3.5HEX 4.75X20 ST CATALOG # 180551 LOT # 993730 COMP LK SCR 3.5HEX 4.75X20 ST CATALOG # 180551 LOT # 807940 COMP PRIMARY STEM 16MM MINI CATALOG # 113636 LOT # 882800 COMP RVS TRAY +5MM CO 44MM CATALOG # 115375 LOT # 350670 BEARING E1 HUMRL STD 44-41MM CATALOG # EP115396 LOT # 429540.

    Description of Event or Problem · 0

    FROM ADDITIONAL INFORMATION RECEIVED, THE PATIENT WAS REVISED. THE PATIENT FURTHER ALLEGED UNKNOWN COMPONENTS WERE NOTED TO BE LOOSE DURING THE REVISION PROCEDURE.

    Description of Event or Problem · 0

    UPON RECEIPT OF INFORMATION RECEIVED AND REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE WAS NOT RELATED TO THE EVENT.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THROUGH PATIENT'S OPERATIVE REPORTS THAT THE PATIENT EXPERIENCED SUBLUXATION APPROXIMATELY TWO MONTHS POST-IMPLANTATION. THE PATIENT WAS TREATED WITH HOME THERAPY EXERCISES. THE PATIENT VISITED THE EMERGENCY ROOM APPROXIMATELY THREE MONTHS POST-IMPLANTATION DUE TO PAIN AND ALLEGED DISLOCATION; HOWEVER, HOSPITAL STAFF CONFIRMED THE PROSTHESIS WAS IN THE CORRECT POSITION AND NO DISLOCATION WAS PRESENT. PATIENT WAS PLACED IN AN ARM SLING. FURTHER, APPROXIMATELY SIX MONTHS POST-IMPLANTATION THE PATIENT HAD FOUR EPISODES OF SUBLUXATION AND WAS PRESCRIBED AT HOME EXERCISE THERAPY.

    Additional Manufacturer Narrative · 1

    (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. UNIQUE IDENTIFIER (UDI) #: N/A. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN GLENOSPHERE. UNKNOWN HUMERAL STEM UNKNOWN HUMERAL BEARING. UNKNOWN GLENOID BASEPLATE. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-01775.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT APPROXIMATELY 3 MONTHS POST IMPLANTATION, THE PATIENT HAS HAD COMPLAINTS OF PAIN AND ALIGNMENT ISSUES OF THE DEVICES IN THE L SHOULDER. THE PATIENT INDICATES THAT THE SHOULDER SEEMS TO POP OUT, AND SURGEON TELLS HIM THAT DEVICES ARE COMING OUT OF ALIGNMENT. THERE HAS BEEN SUGGESTION OF SURGICAL INTERVENTION, BUT NONE TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353492 COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 352060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other