BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW

    MDR report key: 6342348 · Received February 18, 2017

    Report

    Report Number
    0001825034-2017-00761
    Event Type
    Injury
    Date Received
    February 18, 2017
    Date of Event
    January 20, 2017
    Report Date
    September 27, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK113121
    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. IT WAS NOTED THAT INFECTION WAS NOT ACTUALLY PRESENT, AS INITIALLY REPORTED. 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

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. PART AND LOT PRODUCT IDENTIFICATION WAS FILLED OUT AS UNKNOWN AS WE ARE NOT SURE WHICH OF THE TWO SCREWS WERE UTILIZED IN THE PRIMARY PROCEDURE AND THUS REMOVED. THE POSSIBLE SCREWS IDENTIFICATION ARE AS FOLLOWS: PART#: 115396 LOT#: 448240 MANUFACTURER DATE OF: DEC 13, 2016 STERILIZATION DATE OF: (B)(6) 2026 PART#: 115397 LOT#: 310350 MANUFACTURER DATE OF: MAY 26, 2016 STERILIZATION DATE OF: MAY 26, 2026. CONCOMITANT MEDICAL PRODUCTS: 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. THIS REPORT IS NUMBER 2 OF 2 MDRS FOR THE SAME PATIENT (REFERENCE 0001825034-2017-00545/00761).

    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.

    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
    124711 COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R