BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE MINI BASEPLATE

    MDR report key: 6844544 · Received September 6, 2017

    Report

    Report Number
    0001825034-2017-06891
    Event Type
    Injury
    Date Received
    September 6, 2017
    Date of Event
    January 20, 2017
    Report Date
    September 27, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT-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, GLENOSPHERE CATALOG#:115310 LOT#:365980. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT IS RETAINED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-00545/00761, 0001825034 - 2017 - 00545.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. X-RAY REVIEWER STATED "RIGHT SHOULDER TOTAL ARTHROPLASTY SHOWN IN WHICH THE GLENOSPHERE COMPONENT HAS DISLODGED FROM THE BASEPLATE. THE GLENOSPHERE IS SITUATED WITHIN THE JOINT BUT IS REORIENTED COUNTERCLOCKWISE--THE PORTION THAT NORMALLY FASTENS INTO THE BASEPLATE IS POINTING TOWARDS THE ACROMION. THIS CAUSES MALALIGNMENT OF NORMAL HUMERUS AND GLENOID." DEVICE HISTORY RECORDS (DHR) WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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 PATIENT UNDERWENT A SHOULDER ARTHROPLASTY REVISION SEVENTEEN (17) DAYS POST-IMPLANTATION DUE TO DISASSOCIATION OF THE TAPER FROM THE BASEPLATE. THE GLENOSPHERE, TAPER, AND CENTRAL SCREW WERE REMOVED AND REPLACED AND A LONGER SCREW WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625953 COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE MINI BASEPLATE PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 848580

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R