BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP PRIMARY STEM 14MM MINI

    MDR report key: 8703610 · Received June 17, 2019

    Report

    Report Number
    0001825034-2019-02412
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    May 22, 2019
    Report Date
    November 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K060692
    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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. HOWEVER, IT WAS REPORTED THAT THE STEM WAS POSITIONED AT 50 DEGREES OF RETROVERSION. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO UNINTENTIONAL USER ERROR. 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 · 0

    NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED THREE MONTHS POST-IMPLANTATION TO ADDRESS POSTERIOR HUMERAL DISLOCATION ATTRIBUTED TO MALPOSITIONING OF THE HUMERAL STEM. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499495 COMP PRIMARY STEM 14MM MINI PROSTHESIS, EXTREMITY KWS ZIMMER BIOMET, INC. N/A 954190

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 113053 , LOT 294880 MODULAR HEAD| 118001, LOT 886230 TAPER ADAPTER| 113053 , LOT 294880 MODULAR HEAD| 118001, LOT 886230 TAPER ADAPTER