BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALANCE MICROP STEM 10X80MM RT

    MDR report key: 3771323 · Received April 24, 2014

    Report

    Report Number
    0001825034-2014-03219
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    March 28, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK050251
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. THIS REPORT IS NUMBER 1 OF 8 MDRS FILED FOR THE SAME EVENT (1825034-2014-03219 & 1825034-2015-02091 & 02092 & 02093 & 02094 & 02095 & 02096 & 02097).

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION THAT WAS REPORTED IN ERROR ON THE INITIAL REPORT.

    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 IS (OR MAY BE) NEEDED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A 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 RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, LOOSENING, TISSUE NECROSIS AND ELEVATED METAL ION LEVELS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. 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 RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, LOOSENING, TISSUE NECROSIS AND ELEVATED METAL ION LEVELS. PATIENT'S LEGAL COUNSEL REPORTS A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. 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 NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2012 DUE TO PAIN AND POSSIBLE ADVERSE TISSUE REACTION TO METAL ON METAL IMPLANT. OPERATIVE REPORT FURTHER NOTED SEROSANGUINEOUS FLUID, MULTILOCULATED PSEUDOTUMOR, SOFT TISSUE REACTION, SCRATCHES ON THE FEMORAL HEAD AND ACETABULAR CUP, AND CORROSION ON TAPER ADAPTER AND FEMORAL HEAD WERE FOUND. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED WITH A CERAMIC HEAD AND AN ACTIVE ARTICULATION POLYETHYLENE LINER WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT MEDICAL RECORDS INDICATE THAT PATIENT UNDERWENT AN INITIAL LEFT HIP ARTHROPLASTY ON AN UNKNOWN DATE IN (B)(6) 2005. SUBSEQUENTLY, PATIENT WAS REVISED ON THE LEFT HIP DUE TO INFECTION IN (B)(6) 2007 AND HAD ANTIBIOTIC SPACERS PUT IN. REVISION OPERATIVE REPORT NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2010 DUE TO RECURRENT DISLOCATION AND INSTABILITY. DURING THE REVISION, ANTERIOR OSTEOPHYTES ON THE ANTERIOR COLUMN WERE FOUND. THE MODULAR HEAD, ACETABULAR CUP, AND TAPER ADAPTER WERE REMOVED AND REPLACED AND AN ACETABULAR LINER WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT'S REVISION OPERATIVE REPORT NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2011 DUE TO INFECTION AND PAIN. DURING THE REVISION, PURULENT FLUID AND GRANULATION TISSUE WERE FOUND. THE MODULAR HEAD, FEMORAL STEM, ACETABULAR LINER, AND ACETABULAR CUP WERE REMOVED. AN ACETABULAR CUP, OSS STEM, OSS TAPER ADAPTER, AND MODULAR HEAD WERE IMPLANTED. A REVISION OPERATIVE REPORT FROM (B)(6) 2011 NOTED PATIENT UNDERWENT A LEFT HIP REVISION DUE TO PERIPROSTHETIC FRACTURE AND SUSPECTED INFECTION. DURING THE REVISION, THE FRACTURE AT THE JUNCTION OF THE PROXIMAL AND MIDDLE THIRD FEMUR WAS FOUND. THE ACETABULAR CUP, OSS STEM, OSS TAPER ADAPTER, AND MODULAR HEAD WERE REMOVED AND AN ACETABULAR CUP AND LINER, MODULAR HEAD, AND AN OSS FEMORAL STEM WERE IMPLANTED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, LOOSENING, TISSUE NECROSIS AND ELEVATED METAL ION LEVELS. PATIENT'S LEGAL COUNSEL REPORTS A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. 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
    249397 BALANCE MICROP STEM 10X80MM RT PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 452940

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention