BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY-HEAD 3HOLE RCL SHELL 62MM/L24

    MDR report key: 3692652 · Received March 21, 2014

    Report

    Report Number
    0001825034-2014-01947
    Event Type
    Injury
    Date Received
    March 21, 2014
    Date of Event
    May 5, 2003
    Report Date
    February 17, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. 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 1825034-2014-01947/01948).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO CORRECT INFORMATION AND RELAY ADDITIONAL INFORMATION THAT 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. UNDER WARNINGS IT STATES, ¿EXCESSIVE ACTIVITY, TRAUMA AND WEIGHT GAIN HAVE BEEN IMPLICATED WITH PREMATURE FAILURE OF THE IMPLANT BY LOOSENING, FRACTURE, AND/OR WEAR. LOOSENING OF THE IMPLANTS CAN RESULT IN INCREASED PRODUCTION OF WEAR PARTICLES.¿ UNDER POSSIBLE ADVERSE EFFECTS IT STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY.¿ 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 4 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-01947 / 01948 & 2015-00853 / 00854.

    Description of Event or Problem · 1

    PATIENTS LEGAL COUNSEL REPORTS PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6), 2001. SUBSEQUENTLY, ON (B)(6), 2003, PATIENT WAS REVISED DUE TO AN UNKNOWN REASON. IT WAS FURTHER REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6), 2004, DUE TO ALLEGATIONS OF PAIN, DISCOMFORT, INFLAMMATION, SORENESS, DYSFUNCTION, DAMAGE TO SURROUNDING BONE AND TISSUE, ELEVATED METAL ION LEVELS, METALLOSIS AND LOSS OF RANGE OF MOTION. 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 REPORTS PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2001. SUBSEQUENTLY, ON (B)(6) 2003, PATIENT WAS REVISED DUE TO AN UNKNOWN REASON. IT WAS FURTHER REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2004, DUE TO ALLEGATIONS OF PAIN, DISCOMFORT, INFLAMMATION, SORENESS, DYSFUNCTION, DAMAGE TO SURROUNDING BONE AND TISSUE, ELEVATED METAL ION LEVELS, METALLOSIS AND LOSS OF RANGE OF MOTION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S MEDICAL RECORDS INDICATES THAT PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE ON AN UNKNOWN DATE DUE TO AN ACETABULAR FRACTURE. OPERATIVE REPORT DATED (B)(6) 2001 NOTES A REVISION PROCEDURE WAS PERFORMED TO REMOVE FIXATION HARDWARE AND TO CONVERT PATIENT TO RIGHT TOTAL HIP ARTHROPLASTY. TOTAL HIP COMPONENTS WERE IMPLANTED AND COMPETITOR CERCLAGE CABLES WERE UTILIZED TO STABILIZE THE ACETABULAR FRACTURE. A FURTHER OPERATIVE REPORT DATED (B)(6), 2003 NOTES THAT A REVISION WAS PERFORMED DUE TO LOOSENING OF ACETABULAR COMPONENT, FLUID WITHIN THE JOINT, AND NON-UNION OF THE ACETABULAR FRACTURE. THE MODULAR HEAD AND ACETABULAR CUP WERE REPLACED AND A COMPETITOR RECONSTRUCTION PLATE WAS IMPLANTED. OPERATIVE REPORT DATED (B)(6) 2004 NOTES THAT A FURTHER REVISION WAS PERFORMED DUE A FEMORAL FRACTURE AND LOOSENING OF THE ACETABULAR COMPONENT. THE MODULAR HEAD AND ACETABULAR CUP WERE REPLACED WITH A BIOMET HEAD, COMPETITOR ACETABULAR COMPONENTS, AND A COMPETITOR CABLE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168386 MALLORY-HEAD 3HOLE RCL SHELL 62MM/L24 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 065310

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| R