BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD -6MM NK

    MDR report key: 3618944 · Received February 10, 2014

    Report

    Report Number
    0001825034-2014-00674
    Event Type
    Injury
    Date Received
    February 10, 2014
    Date of Event
    February 28, 2011
    Report Date
    July 14, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK062997
    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 PRODUCT IDENTIFICATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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 - 11-173661, LOT NUMBER - 062630, EXPIRATION DATE - SEPTEMBER 30, 2018, MANUFACTURE DATE ¿ SEPTEMBER 26, 2008. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 11-173660, LOT NUMBER - 463610, EXPIRATION DATE - MARCH 31, 2017, MANUFACTURE DATE ¿ MARCH 21, 2007. 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 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03805).

    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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. PMA/510(K) NUMBER. MANUFACTURE DATE ¿ UNKNOWN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    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.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86589 M2A 38MM MOD HD -6MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 463610

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R