BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM M2A HI CARBON HD STD NK

    MDR report key: 3812230 · Received May 15, 2014

    Report

    Report Number
    0001825034-2014-04071
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    October 1, 2014
    Report Date
    April 27, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04071 / 04072).

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    LEGAL COUNSEL REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, LACK OF MOBILITY, METALLOSIS, METAL POISONING, AND ELEVATED METAL ION LEVELS. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THE PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2014. THE REASON FOR REVISION WAS ELEVATED METAL IONS, PAIN, AND SYSTEMIC TOXICITY ASSOCIATED WITH HYPER COBALTISM. OPERATIVE REPORT FURTHER NOTED FLUID, ADVERSE LOCAL SOFT TISSUE RESPONSE, CORROSION AT TAPER JUNCTION BETWEEN HEAD AND TRUNNION, AND OSTEOPENIA IN THE ACETABULUM. THE ACETABULAR LINER, CUP, AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    LEGAL COUNSEL REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, LACK OF MOBILITY, METALLOSIS, METAL POISONING, AND ELEVATED METAL ION LEVELS. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290092 28MM M2A HI CARBON HD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 326230

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R