BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP STD 36MM

    MDR report key: 6945120 · Received October 12, 2017

    Report

    Report Number
    0001825034-2017-08281
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    October 13, 2014
    Report Date
    October 9, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCTS: TEM#XL-115365; LOT#821540 ¿ ARCOM XL 44-36 RTNV+3 HMRL BRG, THERAPY DATES - IMPLANTED (B)(6) 2014; EXPLANTED (B)(6) 2014. ROOT CAUSE DETERMINED TO BE PATIENT NONCOMPLIANCE DUE TO ALZHEIMERS DISEASE. CONDITIONS ARE ADDRESSED IN THE PACKAGE INSERT. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL ISSUES REPORTED FOR THESE PARTS. RELAYED RESULTS TO SALES REP VIA EMAIL ON (B)(6) 2014. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL ISSUES REPORTED FOR ITEM: 115310/LOT: 817990 COMBINATION. EXTERNAL FACTORS, I.E., PATIENT¿S CONDITION ETC., DEVICE NOT RETURNED; KNOWN INHERENT RISK OF PROCEDURE. RISKS ASSOCIATED WITH REPORTED CONDITION ARE ADDRESSED THROUGH THE WARNINGS IN THE PACKAGE INSERT AS A PART OF DESIGN CONTROL RISK MANAGEMENT. ASSOCIATED PACKAGE INSERT (B)(4), THERE ARE WARNINGS IN THE PACKAGE INSERT, UNDER CONTRAINDICATIONS, NUMBER 1 STATES, "UNCOOPERATIVE PATIENT OR PATIENT WITH NEUROLOGIC DISORDERS WHO IS INCAPABLE OR UNWILLING TO FOLLOW DIRECTIONS." UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 9 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY OR EXCESSIVE ACTIVITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." 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 WAS INITIALLY IMPLANTED ON (B)(6) 2014. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO DISLOCATION. THE DOCTOR DOES NOT BELIEVE IT IS THE FAULT OF BIOMET PRODUCTS AND NOTED THAT THE PATIENT WAS NONCOMPLIANT DUE TO ALZHEIMERS DISEASE. THE DOCTOR WAS NOT ABLE TO REDUCE, SO AN OPEN REDUCTION WAS PERFORMED. TAPER ADAPTER, GLENOSPHERE, TRAY, AND POLY REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724257 COMP RVRS SHLDR GLNSP STD 36MM PROSTHESIS - SHOULDER PAO ZIMMER BIOMET, INC. N/A 817990

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R