BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-ANGULAR HUM HD COCR 40X19MM

    MDR report key: 6927670 · Received October 7, 2017

    Report

    Report Number
    0001825034-2017-07276
    Event Type
    Injury
    Date Received
    October 7, 2017
    Date of Event
    July 11, 2017
    Report Date
    October 11, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    PK032895
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 111001, MOSAIC +10MM PROXIMAL BODY, 806050, 111027, MOSAIC LONG TISSUE ATTACH SLV, 568470, 150475, OSS LG HEAD SM TRD LOCK SCREW, 929750, 178512, CPS NUT CO-CR-MO ALLOY, 159340, UNKNOWN, UNKNOWN, 182500, 178784, CPS SHRT MT XXS SPDL 400 HA NP, 066610, 178951, CPS 4CM HMRL MT ADAP 30 D RET, 172760, 111004, MOSAIC MOD PROX HMRL SEG 110MM, 77042. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05981. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ROOT CAUSE REMAINS UNDETERMINED. 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 A SHOULDER ARTHROPLASTY PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO LIMITED RANGE OF MOTION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LIMITED RANGE OF MOTION. INVOICE INDICATES THAT COMPREHENSIVE SRS COMPONENTS WERE IMPLANTED. NO ADDITIONAL COMPLICATIONS WERE NOTED AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707121 BI-ANGULAR HUM HD COCR 40X19MM PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 321730

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R