BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SRS PROXIMAL BODY - LG 42MM

    MDR report key: 6882342 · Received September 21, 2017

    Report

    Report Number
    0001825034-2017-07247
    Event Type
    Injury
    Date Received
    September 21, 2017
    Date of Event
    April 14, 2015
    Report Date
    October 11, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    PK111746
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 211233, COMPREHENSIVE SRS MODULAR STEM 12X75MM, UNKNOWN; UNKNOWN, UNKNOWN BASEPLATE, UNKNOWN; UNKNOWN, UNKNOWN HUMERAL TRAY, UNKNOWN; UNKNOWN, UNKNOWN BEARING, UNKNOWN. REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 07248. 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. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS AND OPERATIVE NOTES. RADIOGRAPHS WERE REVIEWED BY OPERATIVE SURGEON. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 THE PATIENT UNDERWENT LEFT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, ON THREE OCCASIONS, THE PATIENT EXPERIENCED RECURRENT DISLOCATIONS THAT WERE TREATED WITH REDUCTION UNDER ANESTHESIA. THE PATIENT WAS LATER REVISED DUE TO RECURRING DISLOCATION. IT IS REPORTED THAT THE PATIENT EXPERIENCED INSTABILITY AS A COMPLICATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED A DISLOCATION/SUBLUXATION WITH INSTABILITY APPROXIMATELY THREE (3) WEEKS POST-IMPLANTATION. THIS WAS RESOLVED FIVE (5) MONTHS POST-OP BY REVISION OF A LINKED PROSTHESIS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664518 COMPREHENSIVE SRS PROXIMAL BODY - LG 42MM PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R