BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP STD 36MM

    MDR report key: 7138996 · Received December 21, 2017

    Report

    Report Number
    0001825034-2017-11252
    Event Type
    Injury
    Date Received
    December 21, 2017
    Date of Event
    November 9, 2017
    Report Date
    February 22, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: XL-115364, ARCOM XL 44-36 STD +3 HMRL BRG, 358620, 115370, COMP RVS TRAY CO 44MM, 920670, 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, 984240. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 11253.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION IDENTIFIED WEAR MARKS ON THE TAPER AND WEAR MARKS ON THE SPHERICAL RADIUS OF THE GLENOSPHERE. X-RAY REVIEW SHOWED: LEFT SHOULDER REVERSE ARTHROPLASTY AGAIN SEEN WITH EVIDENCE OF AN ANTERIOR SHOULDER DISLOCATION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT SHOULDER PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION. THE BASEPLATE WAS LEFT IMPLANTED WHILE THE GLENOSPHERE AND HUMERAL TRAY AND BEARING WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919403 COMP RVRS SHLDR GLNSP STD 36MM PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 371570

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R