BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING

    MDR report key: 6944080 · Received October 12, 2017

    Report

    Report Number
    0001825034-2017-08536
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    July 3, 2017
    Report Date
    October 12, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE, CATALOG#: 115310, LOT#: 988500 COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW, CATALOG#: 115395, LOT#: 430530 COMPREHENSIVE SHOULDER MINI HUMERAL STEM, CATALOG#: 113632, LOT#: 430770 COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING SCREW, CATALOG#: 180551, LOT#: 225090 COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE MINI BASEPLATE, CATALOG#: 010000589, LOT#: 415160 COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING SCREW, CATALOG#: 180552, LOT#: 446170 COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING SCREW, CATALOG#: 180551, LOT#: 870060 COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING SCREW, CATALOG#: 180550, LOT#: 724660 COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY W LOCKING RING, CATALOG#: 115370, LOT#: 931490. MULTIPLE MDR REPOTS WERE FILLED FOR THIS EVENT: 0001825034-2017-06881, 06896, 06897, 06898, 06899, 08532, 08533, 08534, 08535, 08536. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. 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 PATIENT UNDERWENT LEFT SHOULDER 2-STAGE REVISION DUE TO INFECTION. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724011 COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 355870

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R