BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER 6.5MM CENTRAL SCREW

    MDR report key: 6507354 · Received April 20, 2017

    Report

    Report Number
    0001825034-2017-02643
    Event Type
    Injury
    Date Received
    April 20, 2017
    Report Date
    October 11, 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
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    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) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    (B)(6). PRODUCT IS CURRENTLY NOT EXPECTED TO RETURN TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02643 - 02645 AND 0001825034-2017-02647 - 02469; 0001825034-2016-04993 - 04996.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT: COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE, CATALOG#: 115323, LOT#: 555070; COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY, CATALOG#: 115370, LOT#: 744590; VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR, CATALOG#: 118001, LOT#: 543490; COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING, CATALOG#: XL-115367, LOT#: 970780; FIXED LOCKING SCREW, CATALOG#: 180503, LOT#: 721310; FIXED LOCKING SCREW, CATALOG#: 180505, LOT#: 448010; FIXED LOCKING SCREW, CATALOG#: 180501, LOT#: 491850; FIXED LOCKING SCREW, CATALOG#: 180500, LOT#: 404300; COMPREHENSIVE SHOULDER PRIMARY STEM, CATALOG#: 113653, LOT#: 464950. 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

    LEGAL COUNSEL FOR THE PATIENT IS REPORTING THAT THE PATIENT HAS INDICATED THE NEED FOR A POSSIBLE REVISION DUE TO THEIR SHOULDER BEING "BROKE" AND UNSPECIFIED COMPLICATIONS WITH A REVERSE SHOULDER ARTHROPLASTY APPROXIMATELY 4 YEARS POST-IMPLANTATION. NO REVISION HAS BEEN REPORTED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289813 COMPREHENSIVE REVERSE SHOULDER 6.5MM CENTRAL SCREW PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 732670

    Patients

    Seq Age Sex Outcome Treatment
    1 Other