BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPREHENSIVE REVERSE SHOULDER E1 HUMERAL BEARING

    MDR report key: 6747397 · Received July 27, 2017

    Report

    Report Number
    0001825034-2017-05242
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Date of Event
    June 22, 2017
    Report Date
    July 27, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK113121
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UDI #: (B)(4). CONCOMITANT MEDICAL PRODUCT: COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING, CATALOG#: 115370, LOT#: 271900. COMPREHENSIVE SHOULDER SYSTEM PRIMARY SHOULDER STEM, CATALOG#: 113648, LOT#: 222190. COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING, CATALOG#: EP-115394, LOT#: 127770. COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE, CATALOG#: 115313, LOT#: 877220. COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE MINI BASEPLATE WITH TAPER ADAPTER, CATALOG#: 010000589, LOT#: 909560. COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW, CATALOG#: 115383, LOT#: 425390. COMPREHENSIVE REVERSE SHOULDER LOCKING SCREW, CATALOG#: 180551, LOT#: 046030. COMPREHENSIVE REVERSE SHOULDER LOCKING SCREW, CATALOG#: 180552, LOT#: 232780. COMPREHENSIVE REVERSE SHOULDER NON-LOCKING SCREW, CATALOG#: 180557, LOT#: 424000. COMPREHENSIVE REVERSE SHOULDER NON-LOCKING SCREW, CATALOG#: 180558, LOT#: 481820. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS DISCARDED BY THE HOSPITAL. 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 IS REPORTED THAT THE HUMERAL BEARING WOULD NOT ASSEMBLE WITH THE HUMERAL TRAY DURING REVERSE SHOULDER ARTHROPLASY SURGERY. THE SURGEON FINISHED THE SURGERY WITH AN ALTERNATIVE BEARING. NO ADVERSE EVENT IS REPORTED DUE TO THIS EVENT. NO OTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528153 COMPREHENSIVE REVERSE SHOULDER E1 HUMERAL BEARING PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 291050

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)