BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 60MM

    MDR report key: 3143098 · Received June 3, 2013

    Report

    Report Number
    0001825034-2013-01779
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    October 2, 2012
    Report Date
    September 22, 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, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01779 / 01782).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED ON THE LEFT HIP ON (B)(6) 2012 AND THE RIGHT HIP ON (B)(6) 2013, DUE TO PATIENT ALLEGATIONS OF ELEVATED COCR LEVELS, PAIN, AND DETERIORATION IN MOBILITY. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. 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'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED ON THE LEFT HIP ON (B)(6) 2012 AND THE RIGHT HIP ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF ELEVATED COCR LEVELS, PAIN, AND DETERIORATION IN MOBILITY. ADDITIONAL INFORMATION RECEIVED INDICATES THE REVISION PROCEDURE PERFORMED ON (B)(6) 2012 WAS DUE TO IMPINGEMENT.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. LEGAL COUNSEL FOR PATIENT FURTHER REPORTED THAT A LEFT HIP REVISION OCCURRED ON (B)(6) 2012 AND THAT A RIGHT HIP REVISION OCCURRED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF ELEVATED COCR LEVELS, PAIN, AND DETERIORATION IN MOBILITY. ADDITIONAL INFORMATION RECEIVED INDICATES THAT PATIENT WAS ENROLLED IN A CLINICAL STUDY. THE LEFT HIP REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS DUE TO IMPINGEMENT. THE RIGHT HIP REVISION PROCEDURE THAT OCCURRED ON (B)(6) 2013 WAS DUE TO AN OVERSIZED COMPONENT; HOWEVER, INFORMATION WAS NOT PROVIDED TO INDICATE WHICH COMPONENT WAS OVERSIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244531 M2A-38 CUP NON FLARED SZ 60MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 277060

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R