BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 3800691 · Received May 8, 2014

    Report

    Report Number
    0001825034-2014-03682
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    June 11, 2012
    Report Date
    September 3, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. THIS REPORT IS NUMBER 2 OF 10 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-03681 / 03684 AND 2014-07644 / 07649).

    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 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY." NUMBER 14 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 2 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-03681/03684).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005 AND LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A LEFT HIP REVISION PROCEDURE OCCURRED ON (B)(6) 2009 DUE TO PATIENT ALLEGATIONS OF LOOSENING AND PAIN OF THE HIP AND GROIN. LEGAL COUNSEL REPORTED THAT A RIGHT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, LOOSENING AND DIFFICULTY WITH WEIGHT BEARING. A REVIEW OF THE INVOICE HISTORY CONFIRMED ALL SURGERY DATES AND INDICATES THE MODULAR HEAD, ACETABULAR CUP AND TAPER ADAPTER 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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005 AND LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A LEFT HIP REVISION PROCEDURE OCCURRED ON (B)(6) 2009 DUE TO PATIENT ALLEGATIONS OF LOOSENING AND PAIN OF THE HIP AND GROIN. LEGAL COUNSEL REPORTED THAT A RIGHT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, LOOSENING AND DIFFICULTY WITH WEIGHT BEARING. A REVIEW OF THE INVOICE HISTORY CONFIRMED ALL SURGERY DATES AND INDICATES THE MODULAR HEAD, ACETABULAR CUP AND TAPER ADAPTER 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. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES RIGHT HIP REVISION PERFORMED ON (B)(6) 2012 WAS DUE TO A LOOSE ACETABULAR COMPONENT. THE PATIENT'S OPERATIVE REPORT NOTED TISSUE STAINING, FLUID, AND THE LOOSE ACETABULAR COMPONENT. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES A RIGHT HIP REVISION WAS PERFORMED ON (B)(6) 2014 DUE TO A LOOSE ACETABULAR COMPONENT. THE PATIENT'S OPERATIVE REPORT NOTED ACETABULAR PROTRUSION WITH POSSIBLE INFECTION AND PERFORMED IRRIGATION/DEBRIDEMENT AND GREATER TROCHANTERIC OSTEOTOMY; ALSO NOTED SCAR TISSUE AND A LOOSE ACETABULAR COMPONENT. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES RIGHT HIP REVISION WAS PERFORMED ON (B)(6) 2014 DUE TO PAIN AND A LOOSE ACETABULAR COMPONENT. THE PATIENT'S OPERATIVE REPORT NOTED EVIDENCE OF DEFECT OF THE POSTERIOR WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278682 M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 618430

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R