BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE +6

    MDR report key: 6358434 · Received February 24, 2017

    Report

    Report Number
    0001825034-2017-00921
    Event Type
    Injury
    Date Received
    February 24, 2017
    Date of Event
    January 26, 2017
    Report Date
    September 25, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS NUMBER 2 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2017-00919 / 00922 / 00926 / 00936).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IT IS UNKNOWN WHICH GLENOSPHERE WAS IMPLANTED, AS TWO (2) WERE INDICATED ON THE INVOICE. THE OTHER POSSIBLE GLENOSPHERE IS: COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE, CATALOG#: 115310, LOT#: 196530, EXP DATE: MAY 19, 2026, (B)(4), MFG DATE: MAY 19, 2016 CONCOMITANT MEDICAL PRODUCT: COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING, CATALOG#: XL-115364, LOT#: 855080; COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE MINI BASEPLATE W/ TAPER ADAPTER, CATALOG#: 010000589; COMPREHENSIVE SHOULDER HUMERAL FRACTURE STEM, CATALOG#: 12-113562, LOT#: 430310; COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY W/ LOCKING RING, CATALOG#: 115370, LOT#: 148930; FIXED LOCKING SCREW, CATALOG#: 180550, LOT#: 914840; COMPREHENSIVE REVERSE FIXED LOCKING SCREW, CATALOG#: 180552, LOT#: 186760; FIXED LOCKING SCREW, CATALOG#: 180555, LOT#: 264120; COMPREHENSIVE REVERSE CENTRAL SCREW, CATALOG#: 115397, LOT#: 327030; COMPREHENSIVE REVERSE STEINMANN, CATALOG#: 405800, LOT#: 423030; COMPREHENSIVE REVERSE DRILL, CATALOG#: 405889, LOT#: 977480; COMPREHENSIVE REVERSE DRILL, CATALOG #: 405883, LOT#: 328460. 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 WAS REPORTED THAT A PATIENT UNDERWENT SHOULDER ARTHROPLASTY REVISION DUE TO INFECTION. THE SURGEON REMOVED THE IMPLANTS AND REPLACED THEM WITH CEMENT SPACER MOLDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT SHOULDER ARTHROPLASTY REVISION DUE TO INFECTION 5 MONTHS POST-IMPLANTATION. THE SURGEON REMOVED THE IMPLANTS AND REPLACED THEM WITH CEMENT SPACER MOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140516 COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE +6 PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS NA 502920

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R