BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD STD NK

    MDR report key: 3062539 · Received April 17, 2013

    Report

    Report Number
    0001825034-2013-01018
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    May 8, 2012
    Report Date
    April 29, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 11 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES" 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 1825034-2013-01018 AND 02138).

    Additional Manufacturer Narrative · 1

    EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. 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. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY FURTHER PATIENT INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN A REVIEW OF INVOICE HISTORY CONFIRMS THE HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2003. MEDICAL RECORDS PROVIDED INDICATE PATIENT WAS REVISED ON (B)(6) 2012 DUE TO METALLOSIS, WEAR, ELEVATED METAL ION LEVELS AND TROCHANTERIC AND ACETABULAR OSTEOLYSIS. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THE HEAD AND CUP WERE REMOVED AND REPLACED WITH BIOMET PRODUCT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN A REVIEW OF INVOICE HISTORY CONFIRMS THE HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2003. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THE HEAD AND CUP WERE REMOVED AND REPLACED WITH BIOMET PRODUCT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND FURTHER REPORTED PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES THAT A LEFT HIP ARTHROPLASTY PROCEDURE TOOK PLACE ON (B)(6) 2003. PATIENT MEDICAL RECORDS FURTHER INDICATE THAT A LEFT HIP REVISION PROCEDURE TOOK PLACE ON (B)(6) 2012 DUE TO METALLOSIS, WEAR, ELEVATED METAL ION LEVELS AND TROCHANTERIC AND ACETABULAR OSTEOLYSIS. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION FROM LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF NEGATIVE EFFECTS TO TISSUE, BONES, MUSCLES AND LIGAMENTS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF铠COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164647 M2A 38MM MOD HD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 978300

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R