BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE

    MDR report key: 6342349 · Received February 18, 2017

    Report

    Report Number
    0001825034-2017-00545
    Event Type
    Injury
    Date Received
    February 18, 2017
    Date of Event
    January 20, 2017
    Report Date
    September 6, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, THIS COMPONENT IS DETERMINED TO BE NOT REPORTABLE AS THIS WAS DISASSOCIATION, AND THIS MALFUNCTION SOLELY INVOLVES THE TAPER FROM THE BASEPLATE. THE INITIAL REPORT SHOULD BE VOIDED. 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). THIS REPORT IS NUMBER 1 OF 2 MDR'S FOR THE SAME PATIENT (REFERENCE 0001825034-2017-00545/00761). CONCOMITANT MEDICAL PRODUCTS: ZIMMER HUMERAL STEM CATALOG#: 00434901213 LOT#63325282; ZIMMER POLY LINER CATALOG#: 00434903600 LOT#: 63381078; BIOMET COMPREHENSIVE SCREW CATALOG#: 180557 LOT#: 350240; BIOMET COMPREHENSIVE SCREW CATALOG#: 180550 LOT#: 331050; BIOMET COMPREHENSIVE SCREW CATALOG#180552 LOT#: 070920; COMPREHENSIVE SCREW CATALOG#: 180551 LOT#: 445140.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY REVISION 17 DAYS POST-IMPLANTATION DUE TO DISASSOCIATION OF THE GLENOSPHERE, CAUSED BY INFECTION. THE GLENOSPHERE AND CENTRAL SCREW WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124712 COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS NI 365980

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R