BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING/STANDARD 44MM-41 MM DIA OF CURVE

    MDR report key: 6618039 · Received June 7, 2017

    Report

    Report Number
    0001825034-2017-03671
    Event Type
    Injury
    Date Received
    June 7, 2017
    Date of Event
    May 4, 2017
    Report Date
    June 20, 2017
    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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS-STEM CATALOG#:113670 LOT#:021080, TRAY CATALOG#:115370 LOT#:521800. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE HOSPITAL HAS RETAINED THE PRODUCT. THE INVESTIGATION IS IN PROCESS. 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: 0001825034-2017-03667, 0001825034-2017-03670.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERSE SHOULDER ARTHROPLASTY REVISION APPROXIMATELY THIRTY-THREE MONTHS POST-OPERATIVELY DUE TO DISLOCATION FOLLOWING A FALL AND LOOSENING. DURING THE REVISION, IT WAS FURTHER NOTED THAT THE PATIENT HAD AN INFECTION, HOWEVER IT IS UNKNOWN HOW LONG POST-OPERATIVELY THE ONSET OF INFECTION BEGAN. ATTEMPTS HAVE BEEN MADE, AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401235 COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING/STANDARD 44MM-41 MM DIA OF CURVE PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 721190

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R