BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HEAD STD NK

    MDR report key: 3802873 · Received May 9, 2014

    Report

    Report Number
    0001825034-2014-03802
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    June 7, 2009
    Report Date
    April 11, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    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.¿ NUMBER 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ NUMBER 14 STATES, ¿POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03802 / 03803).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2009 DUE TO PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DYSFUNCTION, ELEVATED METAL ION LEVELS, LOSS OF RANGE OF MOTION, METAL POISONING AND METALLOSIS. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE. INVOICE HISTORY REVEALED THE REVISION PROCEDURE WAS ON (B)(6) 2009 AND THAT THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENTS NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280924 28MM DIA COCR MOD HEAD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 860090

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R