BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FEMORAL 11X142

    MDR report key: 2761087 · Received September 26, 2012

    Report

    Report Number
    0001825034-2012-01675
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    November 6, 2012
    Report Date
    March 26, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION REGARDING THE REASON FOR THE REVISION PROCEDURE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL INDICATES PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2012.

    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 FIFTEEN 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 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01673 / 01675).

    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

    PATIENT REPORTED TO HAVE UNDERGONE HIP ARTHROPLASTY ON (B)(6) 2002 AND SUBSEQUENTLY ALLEGED ELEVATED METAL IONS. ADDITIONAL INFORMATION SUBMITTED BY PATIENT'S LEGAL COUNSEL INDICATES THAT PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2012. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS DUE TO METALLOSIS. THE OPERATIVE NOTES CONFIRM THAT THE HEAD, CUP, AND TAPER WERE REMOVED AND REPLACED. 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

    PATIENT REPORTED TO HAVE UNDERGONE HIP ARTHROPLASTY ON (B)(6) 2002 AND SUBSEQUENTLY ALLEGED ELEVATED METAL IONS. ADDITIONAL INFORMATION SUBMITTED BY PATIENT'S LEGAL COUNSEL INDICATES THAT PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2012. 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

    PATIENT REPORTED UNDERGOING M2A HIP ARTHROPLASTY ON (B)(6) 2002. SUBSEQUENTLY, PATIENT ALLEGES INCREASED METAL ION LEVELS AND THE NEED FOR A REVISIONS PROCEDURE. NO KNOWN REVISION DATE HAS BEEN REPORTED. 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
    1 TAPERLOC POR FEMORAL 11X142 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 381390

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R