BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT GLENOID REVERSE SHOULDER KIT CUSTOM-MADE WITH 4.75 LOCKING SCREW HOLES

    MDR report key: 6111066 · Received November 17, 2016

    Report

    Report Number
    0001825034-2016-04728
    Event Type
    Injury
    Date Received
    November 17, 2016
    Report Date
    March 22, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSD
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE IS (OR MAY BE) NEEDED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH AND CORRECTED INFORMATION. UDI #: (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 113630, COMP PRIMARY STEM 10MM MINI, LOT # 380720, CATALOG #: XL-115365, ARCOM XL 44-36 RTNV+3, LOT # 961510, CATALOG #: 115370, COMP RVRS TRAY CO 44MM, LOT # 648700, CATALOG #: 115310, COMP RVRS SHLDR GLNSP, LOT # 529440, CATALOG #: 180554, COMP LK SCR 3.5 HEX 4.7, LOT # 489310, CATALOG #: 180550, COMP LK SCR 3.5 HEX 4.7, LOT # 224560, CATALOG #: 405889, COMP RVS 2.7MM DIA DRL, LOT # 804280, CATALOG #: 180553, COMP LK SCR 3.5 HEX 4.7, LOT # 399140, CATALOG #: 180556, COMP LK SCR 3.5 HEX 4.7, LOT # 803130, CATALOG #: 405889, COMP RVS 2.7MM DIA DRL, LOT # 804210. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE PART REMAINS IMPLANTED, AND THUS WAS NOT RETURNED. DEVICE HISTORY RECORDS WERE REVIEWED, WITH NO DISCREPANCIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    A SHOULDER REVISION PROCEDURE HAS BEEN INDICATED DUE TO SUBLUXATION. IT WAS REPORTED THAT THE IMPLANTED BASEPLATE IS ANTEVERTED. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A SHOULDER REVISION PROCEDURE HAS BEEN INDICATED APPROXIMATELY EIGHT MONTHS POST-IMPLANTATION DUE TO SUBLUXATION WHEN THE PATIENT IS IN ABDUCTION. IT IS FURTHER REPORTED THE CUSTOM GLENOID COMPONENT IS ALSO ANTEVERTED AND THE POSSIBLE BONEY OVERGROWTH OF THE IMPLANT MAY BE PRESENT. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759732 CT GLENOID REVERSE SHOULDER KIT CUSTOM-MADE WITH 4.75 LOCKING SCREW HOLES PROSTHESIS, SHOULDER HSD BIOMET ORTHOPEDICS N/A 672760

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention