BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER

    MDR report key: 2103061 · Received May 25, 2011

    Report

    Report Number
    1825034-2011-00411
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 25, 2008
    Report Date
    May 20, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS ORIGINALLY REPORTED ON MANUFACTURER REPORT NUMBER 1825034-2011-00228 WITH MULTIPLE OTHER EVENTS. FURTHER INFORMATION PROVIDED BY SURGEON AND A REVIEW OF INVOICE HISTORY REVEALED THE PRODUCT IDENTIFICATION OF COMPONENT(S) RELATED TO THIS EVENT. ATTEMPTS WERE MADE TO IDENTIFY ALL OF THE EVENTS REPORTED; HOWEVER, NOT ALL EVENTS COULD BE CONFIRMED VIA INVOICE HISTORY. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICES WERE STERILIZED IN ACCORDANCE WITH (B)(4). THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "EARLY OR LATE POSTOPERATIVE, INFECTION, AND ALLERGIC REACTION." (B)(4).

    Additional Manufacturer Narrative · 1

    IN REVIEW, THE JOURNAL ARTICLE IS RELAYING INFORMATION THAT WAS PREVIOUSLY REPORTED IN MDR NUMBERS 1825034-2011-00228 & 1825034-2011-00402/433. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED VERY PRELIMINARY INFORMATION REGARDING SEVERAL REVISIONS WHICH WERE OUTLINED IN A PRESENTATION CONDUCTED BY A SURGEON AT (B)(6). FURTHER INFORMATION PROVIDED BY THE SURGEON AND A REVIEW OF INVOICE HISTORY CONFIRMED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003 AND THAT A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2008 DUE TO INFECTION. THE MODULAR HEAD WAS REMOVED AND REPLACED. INFORMATION PROVIDED BY SURGEON INDICATES RADICAL DEBRIDEMENT WAS PERFORMED; HOWEVER, IT IS NOT KNOWN WHAT OTHER COMPONENTS, IF ANY, WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 196160

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R