BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL 44-36 RTNV+3 HMRL BRG

    MDR report key: 6933766 · Received October 10, 2017

    Report

    Report Number
    0001822565-2017-06931
    Event Type
    Injury
    Date Received
    October 10, 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

    CONCOMITANT MEDICAL PRODUCTS: ITEM#115310; LOT#817990 ¿ COMP RVRS SHLDR GLNSP STD 36MM THERAPY DATES - IMPLANTED: JUN 2, 2014; EXPLANTED: OCT 14, 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. PRODUCT INFORMATION UPDATED: REVIEW OF COMPLAINT HISTORY FOUND ¿NO¿ ADDITIONAL ISSUES REPORTED FOR ITEM: (B)(4)/LOT: 821540 COMBINATION. REVISION DUE TO DISLOCATION: 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, 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
    718390 ARCOM XL 44-36 RTNV+3 HMRL BRG PROSTHESIS - SHOULDER PAO ZIMMER BIOMET, INC. N/A 821540

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R