BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX56MM

    MDR report key: 3120732 · Received May 20, 2013

    Report

    Report Number
    0001825034-2013-01563
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    May 2, 2011
    Report Date
    October 29, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. PRODUCT IS STILL IMPLANTED / HAS NOT BEEN REVISED.

    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 2 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01562 / 01565).

    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

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 2 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01562 / 01565 & -05364 /-5365).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT A BILATERAL PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT UNDERWENT A REVISION ON AN UNKNOWN SIDE ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, METAL POISONING, METALLOSIS, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION AND FLUID BUILD UP AROUND THE JOINT. 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 A BILATERAL PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT UNDERWENT A REVISION ON AN UNKNOWN SIDE ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, METAL POISONING, METALLOSIS, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION AND FLUID BUILD UP AROUND THE JOINT. 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 INDICATE THAT THE REVISION THAT TOOK PLACE ON (B)(6) 2011 WAS DUE TO PAIN AND A POSTERIOR CYSTIC MASS. REVISION OPERATIVE REPORT DATED (B)(6) 2011 NOTED THE PRESENCE OF YELLOWISH CLOUDY FLUID, SCLEROTIC BONE, AND SYNOVIAL TISSUE. REVISION OPERATIVE REPORT DATED (B)(6) 2011 NOTED THE PRESENCE OF A PSEUDOTUMOR, METALLOSIS, GRANULATION TISSUE. A SMALL CORONAL SPLIT IN THE FEMORAL SHAFT OCCURRED DURING REMOVAL OF THE STEM. THE HEAD WAS REMOVED AND REPLACED AND THE CUP WAS REPLACED WITH A COMPETITOR'S CUP. SUBSEQUENTLY, PATIENT MEDICAL RECORDS INDICATE A FURTHER REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND ANTIBIOTIC SPACERS WERE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221806 M2A 1 PC SHELL 38MMX56MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 458880

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R