BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING/STANDARD

    MDR report key: 6490312 · Received April 13, 2017

    Report

    Report Number
    0001825034-2017-02487
    Event Type
    Injury
    Date Received
    April 13, 2017
    Date of Event
    January 3, 2017
    Report Date
    February 7, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED EVENT IS CONFIRMED VIA PHOTOGRAPHS, X-RAYS, AND OPERATIVE NOTES RECEIVED. X-RAY REVIEW SHOWED THAT THE PROSTHESIS WAS DISPLACED AND BROKEN. PHOTOS OF THE TRAY, STEM, AND BEARING IDENTIFIED THAT THE TRAY WAS SCRATCHED, NICKED, AND THE TAPER WAS MISSING. THE STEM WAS SCRATCHED, NICKED, PITTED AND THE TAPER WAS FRACTURED OFF FROM THE TRAY AND REMAINS IN THE STEM. THE BEARING WAS ALSO WORN, DENTED AND HAD FADED MARKINGS. PHOTOS OF DEVICES; TRAY STEM AND BEARING WERE RECEIVED FOR EVALUATION. THE ROOT CAUSE OF THE TRAY FRACTURE IS RELATED TO A PREVIOUSLY ADDRESSED DESIGN DEFICIENCY RELATED TO THE HUMERAL TRAY COMPONENT. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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). UPON REVIEW OF THIS COMPLAINT ON MAR 14, 2017 THE INVOICE WAS PULLED WHICH GIVES US A NEW AWARE DATE FOR THE PRODUCTS THAT HAVE NOT YET BEEN REPORTED. MEDICAL DEVICES-COMPREHENSIVE SCREW CATALOG#:180509 LOT#: 852650, COMPREHENSIVE REVERSE SHOULDER GLENOID BASEPLATE CATALOG#:115330 LOT#:524560, COMPREHENSIVE REVERSE CENTRAL SCREW CATALOG#:115383 LOT#: 256750, COMPREHENSIVE NON LOCKING SCREW CATALOG#:180509 LOT#: 852620, COMPREHENSIVE LOCKING SCREW CATALOG#:180504 LOT#:029360, COMPREHENSIVE LOCKING SCREW CATALOG#:180505 LOT#: 852240, COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE CATALOG#:115310 LOT#:258260, VERSA DIAL TAPER CATALOG#: 118001 LOT#:927850 CUSTOMER HAS NOT YET INDICATED IF THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2017-01423, 0001825034-2017-02483 AND 0001825034-2017-02489.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 RIGHT TOTAL SHOULDER ARTHROPLASTY REVISION APPROXIMATELY SIX (6) YEARS POST-OPERATIVELY DUE TO PAIN, IMPLANT FRACTURE, AND POPPING NOISES IN THE SHOULDER. REVISION OPERATIVE NOTES FURTHER NOTED THICK FIBROTIC CAPSULAR TISSUE, METAL-TINGED FLUID, SMALL PRESENCE OF METALLOSIS, A FRACTURED HUMERAL TRAY IMPLANT WITH THE POST REMAINING IN THE HUMERAL STEM, AND POLYETHYLENE WEAR. THE STEM, TRAY, AND BEARING WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272240 COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING/STANDARD PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 448920

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R