BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 48MM

    MDR report key: 3804135 · Received May 11, 2014

    Report

    Report Number
    0001825034-2014-03805
    Event Type
    Injury
    Date Received
    May 11, 2014
    Date of Event
    February 28, 2011
    Report Date
    July 14, 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
    NY, US
    Reporter Occupation
    ATTORNEY

    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 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." THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 15-105060, LOT NUMBER - 129680, EXPIRATION DATE - SEPTEMBER 30, 2014, - MANUFACTURE DATE ¿ SEPTEMBER 30, 2004. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 15-106060, LOT NUMBER - 474150, EXPIRATION DATE - NOVEMBER 30, 2018, MANUFACTURE DATE ¿ NOVEMBER 20, 2008. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 15-105058, LOT NUMBER - 866000, EXPIRATION DATE - JANUARY 31, 2015, MANUFACTURE DATE ¿ JANUARY 17, 2005. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 15-106048, LOT NUMBER - 042710, EXPIRATION DATE - OCTOBER 31, 2018, MANUFACTURE DATE ¿ OCTOBER 8, 2008. 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 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00674 & 03805).

    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: "LOOSENING OR MIGRATION OF IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY."

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION AND LOSS OF RANGE OF MOTION. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT BLACKENED SYNOVIAL TISSUE AND MINIMAL BONY INGROWTH WERE ALLEGEDLY NOTED DURING THE REVISION PROCEDURE. REVIEW OF INVOICE HISTORY CONFIRMED THE MODULAR HEAD AND ACETABULAR CUP 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

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION AND LOSS OF RANGE OF MOTION. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT BLACKENED SYNOVIAL TISSUE AND MINIMAL BONY INGROWTH WERE ALLEGEDLY NOTED DURING THE REVISION PROCEDURE. REVIEW OF INVOICE HISTORY CONFIRMED THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2011 DUE TO PAIN. OPERATIVE REPORT NOTED THE PRESENCE OF THICK, CLEAR SYNOVIAL FLUID, BLACKENING OF THE SYNOVIUM, BLACK SYNOVIAL TISSUE AND LACK OF BONY INGROWTH ON THE ACETABULAR CUP. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283091 M2A-38 CUP NON FLARED SZ 48MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 042710

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R