BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX52MM

    MDR report key: 3113836 · Received May 15, 2013

    Report

    Report Number
    0001825034-2013-01514
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    August 9, 2013
    Report Date
    July 8, 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
    PATIENT

    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 WARNINGS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." (B)(4).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT BILATERAL HIP ARTHROPLASTY ON (B)(6) 2006 AND (B)(6) 2007. SUBSEQUENTLY, PATIENT ALLEGES THAT A REVISION IS NEEDED DUE TO TUMORS, SOFT TISSUE DAMAGE, AND ELEVATED COBALT AND CHROMIUM LEVELS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT BILATERAL HIP ARTHROPLASTY ON (B)(6) 2006 AND (B)(6) 2007. SUBSEQUENTLY, PATIENT ALLEGES THAT A REVISION IS NEEDED DUE TO TUMORS, SOFT TISSUE DAMAGE, AND ELEVATED COBALT AND CHROMIUM LEVELS. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2013 AND A RIGHT HIP REVISION ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, SOFT TISSUE CHANGES INCLUDING MUSCLE ATROPHY, PSEUDOTUMOR, ADVERSE LOCAL TISSUE REACTION, ELEVATED METAL ION LEVELS, LACK OF MOBILITY, LOSS OF RANGE OF MOTION AND DIFFICULTY AMBULATING. LEGAL DOCUMENT ALLEGES THE PRESENCE OF A PSEUDOTUMOR AND CORROSION AT HEAD AND NECK JOINT DURING THE REVISION PROCEDURES. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT OPERATIVE (OP) NOTES DATED (B)(6) 2013 REPORTS PATIENT WAS REVISED ON THE LEFT HIP DUE TO PAIN AND ELEVATED CHROMIUM AND COBALT LEVELS. REVISION OP REPORT NOTES A PORTION OF THE ABDUCTOR HAD AVULSED. THE HEAD WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT OP NOTES DATED (B)(6) 2013 REPORTS PATIENT WAS REVISED ON THE RIGHT HIP DUE TO PAIN. REVISION OP REPORT NOTES A PORTION OF THE ABDUCTORS WAS NO LONGER IN CONTINUITY DUE TO A SOFT TISSUE PSEUDOTUMOR TYPE REACTION THROUGHOUT THE AREA. OP REPORT FURTHER NOTES CORROSION AT THE JUNCTION BETWEEN THE HEAD AND THE NECK. THE HEAD WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT BILATERAL HIP ARTHROPLASTY ON (B)(6), 2006 AND (B)(6), 2007. SUBSEQUENTLY, PATIENT ALLEGES THAT A REVISION IS NEEDED DUE TO TUMORS, SOFT TISSUE DAMAGE, AND ELEVATED COBALT AND CHROMIUM LEVELS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6), 2013 AND A RIGHT HIP REVISION ON (B)(6), 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, SOFT TISSUE CHANGES INCLUDING MUSCLE ATROPHY, PSEUDOTUMOR, ADVERSE LOCAL TISSUE REACTION, ELEVATED METAL ION LEVELS, LACK OF MOBILITY, LOSS OF RANGE OF MOTION AND DIFFICULTY AMBULATING. LEGAL DOCUMENT ALLEGES THE PRESENCE OF A PSEUDOTUMOR AND CORROSION AT HEAD AND NECK JOINT DURING THE REVISION PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214362 M2A 1 PC SHELL 38MMX52MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 181390

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R