BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R/C II CONSTRAINED LINER SZ 23

    MDR report key: 3821993 · Received May 20, 2014

    Report

    Report Number
    0001825034-2014-04385
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    November 2, 2009
    Report Date
    June 5, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWZ
    PMA / PMN Number
    PK021728
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 2 STATES, "EARLY OR LATE POSTOPERATIVE, INFECTION, AND ALLERGIC REACTION." NUMBER 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ NUMBER 15 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." 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 1825034-2014-04383/04385).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTS PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. PATIENT'S LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO BONE/TISSUE, LACK OF MOBILITY, METAL POISONING, METALLOSIS AND INFECTION. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT UNDERWENT REVISION PROCEDURES ON (B)(6) 2009 AND (B)(6) 2010. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT OPERATIVE (OP) NOTES REPORTS PATIENT UNDERWENT A TWO-STAGE REVISION PROCEDURE. FIRST STAGE WAS PERFORMED ON (B)(6) 2009 DUE TO PAIN, DISLOCATION, SUBLUXATION, METALLOSIS, AND PRESUMED INFECTION. REVISION OP REPORT NOTES THE PRESENCE OF BLACK SYNOVIAL HYPERTROPHY, PURULENT BLACK FLUID WITH PARTICULAR DEBRIS, METALLOSIS, DISLODGED METAL LOCKING RING, AND A GOUGE IN FEMORAL NECK POSSIBLY FROM THE LOCKING METAL RING. OP REPORT FURTHER NOTES THIS PROCEDURE TOOK OVER FIVE HOURS DUE TO DIFFICULT REMOVAL OF FEMORAL COMPONENT. THE RINGLOC LOCKING RING, MODULAR HEAD, AND CONSTRAINED LINER WERE REMOVED AND ANTIBIOTIC SPACERS WERE IMPLANTED. SECOND STAGE WAS PERFORMED ON (B)(6) 2010 WITH ALL COMPONENTS BEING REMOVED AND REPLACED WITH COMPETITOR PRODUCTS.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO BONE/TISSUE, LACK OF MOBILITY, METAL POISONING, METALLOSIS AND INFECTION. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT UNDERWENT REVISION PROCEDURES ON (B)(6) 2009 AND (B)(6) 2010. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE; HOWEVER, AN INVOICE COULD NOT BE LOCATED TO CONFIRM THE REVISION PROCEDURES AND WHICH COMPONENTS WERE REMOVED AND REPLACED DURING THE REVISION PROCEDURES. 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
    300221 R/C II CONSTRAINED LINER SZ 23 PROSTHESIS, HIP KWZ BIOMET ORTHOPEDICS N/A 361380

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R