BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD STD NK

    MDR report key: 4191140 · Received October 21, 2014

    Report

    Report Number
    0001825034-2014-08190
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 16, 2014
    Report Date
    November 11, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-08189 / 08190).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE MATERIAL ANALYSIS, IT WAS NOTED THE COMPONENT SHOWED EVIDENCE OF SCRATCHING, WEAR AND SUBLUXATION OF THE JOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL HIP PROCEDURE ON (B)(6) 2007. SUBSEQUENTLY, PATIENT WAS REVISED DUE TO UNSPECIFIED MECHANICAL COMPLICATION OF INTERNAL JOINT PROSTHESIS AND ADVERSE REACTION TO METAL DEBRIS (ARMD). NO FURTHER DETAIL CONCERNING THE MECHANICAL COMPLICATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669499 M2A 38MM MODULAR HEAD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 474150

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R