BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEHRZ LT PM ANTERIOR GUIDE

    MDR report key: 6800527 · Received August 17, 2017

    Report

    Report Number
    0001825034-2017-06418
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Date of Event
    July 19, 2017
    Report Date
    November 29, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSD
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS: GEHRZ LT PM CNV BSPLT HA CATALOG#: PM0000613 LOT#: 152510. GEHRZ LT PM RMR GD CATALOG#: PM0000614 LOT#: 359890. DEVICE HISTORY RECORD WAS REVIEWED AND THE EVENT IS CONFIRMED BECAUSE THE PMI PARTS WERE LABELED AS A LEFT, HOWEVER, THEY WERE DESIGNED TO BE FOR THE RIGHT SHOULDER. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO LABELING DEFICIENCY. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CONCOMITANT MEDICAL PRODUCTS: GEHRZ LT PM CNV BSPLT HA, CATALOG # PM0000613, GEHRZ LT PM RMR GD, CATALOG # PM0000614. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPOTS WERE FILLED FOR THIS EVENT: 0001825034 - 2017 - 06405, 0001825034 - 2017 - 06415.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PMI PRODUCT WAS RECEIVED LABELED FOR THE LEFT SHOULDER, HOWEVER THE ACCURATE DEVICES FOR THE RIGHT SHOULDER WERE IN THE BOX. THE SURGERY WAS COMPLETED WITHOUT ANY ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580603 GEHRZ LT PM ANTERIOR GUIDE PROSTHESIS, SHOULDER HSD BIOMET ORTHOPEDICS N/A 377330

    Patients

    Seq Age Sex Outcome Treatment
    1