BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNUM TRISPIKE CUP 60ODX54ID

    MDR report key: 3841310 · Received May 30, 2014

    Report

    Report Number
    0001825034-2014-05062
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    February 24, 2011
    Report Date
    October 20, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK062995
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. 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 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, BONE RESORPTION, OR EXCESSIVE UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY.¿ THIS REPORT IS NUMBER 3 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-05059, 05061 / 05063 AND 08439).

    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 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 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05059, 05061 / 05063).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2010 DUE TO PATIENT ALLEGATIONS OF PAIN, LACK OF MOBILITY, AND LOSS OF RANGE OF MOTION. LEGAL COUNSEL FURTHER REPORTED PATIENT UNDERWENT A RIGHT HIP IRRIGATION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2010 AND A REVISION PROCEDURE ON (B)(6) 2011. 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 REVEALED THE RIGHT HIP REVISION PERFORMED ON (B)(6) 2010 WAS DUE TO PAIN. THE PATIENT'S OPERATIVE REPORT NOTED CALCIFICATIONS AROUND THE HIP JOINT AND A SHIFTED ACETABULAR CUP. FURTHER INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEALED THE RIGHT HIP REVISION PERFORMED (B)(6) 2011 WAS DUE TO LOOSENING. THE PATIENT'S OPERATIVE REPORT NOTED METALLOSIS-TYPE FLUID AND THAT THE ACETABULAR COMPONENT HAD MIGRATED VERTICALITY AND INTO THE PELVIC REGION.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2010 DUE TO PATIENT ALLEGATIONS OF PAIN, LACK OF MOBILITY, AND LOSS OF RANGE OF MOTION. LEGAL COUNSEL FURTHER REPORTED PATIENT UNDERWENT A RIGHT HIP IRRIGATION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2010 AND A REVISION PROCEDURE ON (B)(6) 2011. 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
    319407 MAGNUM TRISPIKE CUP 60ODX54ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 788410

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R