BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX50MM

    MDR report key: 3425691 · Received October 23, 2013

    Report

    Report Number
    0001825034-2013-04816
    Event Type
    Injury
    Date Received
    October 23, 2013
    Date of Event
    April 17, 2014
    Report Date
    July 14, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. PMA/510(K) NUMBER. MANUFACTURE DATE ¿ UNKNOWN. THIS REPORT IS NUMBER 25 OF 25 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2010-00591-1 / 00598-1 AND 1825034-2013-04791/04801 AND 04806 AND 04809 AND 04813/04816).

    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.

    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 25 OF 30 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2010-00591-1 / 00598-1 AND 1825034-2013-04791/-04801 AND -04806 AND -04809 AND -04813/-04816 AND 1825034-2014-03541/-03545).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2007, DUE TO RECURRENT DISLOCATION. THE ACETABULAR COMPONENT, POLYETHYLENE LINER, FEMORAL COMPONENT AND MODULAR HEAD WERE REMOVED AND REPLACED. ADDITIONALLY, THE PATIENT WAS REVISED ON (B)(6) 2008, DUE TO INSTABILITY AND A PERIPROSTHETIC FEMUR FRACTURE. THE POLYETHYLENE LINER AND MODULAR HEAD WERE REMOVED AND REPLACED. THE SURGEON ALSO IMPLANTED A TROCHANTER CLAW, BOLT AND CABLE SYSTEM. THEN, ON (B)(6) 2008, PATIENT WAS REVISED DUE TO INSTABILITY AND DISLOCATION. THE MODULAR HEAD WAS REMOVED AND REPLACED. OPERATIVE NOTES STATE THE PRESENCE OF A HEMATOMA AND THAT THE SURGEON PERFORMED IRRIGATION AND DEBRIDEMENT. ON (B)(6) 2008, THE PATIENT WAS REVISED DUE TO INFECTION. SURGEON PERFORMED IRRIGATION AND DEBRIDEMENT AND THE ACETABULAR CUP, POLYETHYLENE LINER AND MODULAR HEAD WERE REMOVED AND REPLACED. ALSO, THE FEMORAL STEM WAS REMOVED AND REPLACED WITH A COMPETITOR CEMENT SPACER MOLD. FINALLY, ON (B)(6) 2008, PATIENT UNDERWENT A STAGE TWO REVISION WHERE THE SURGEON REIMPLANTED TOTAL HIP COMPONENTS. THE MODULAR HEAD, ACETABULAR COMPONENT AND COMPETITOR CEMENT SPACER MOLD WERE REMOVED AND REPLACED. IT IS UNKNOWN DURING WHICH PROCEDURE THE TROCHANTER CLAW AND CABLE SYSTEM WERE REMOVED AND REPLACED. A REVIEW OF RADIOGRAPHIC IMAGES REVEALED THAT THE PATIENT IS BILATERAL. THEREFORE, THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. RADIOGRAPHS SHOW THE BIOMET CUP HAS MIGRATED VERTICALLY. THERE HAS BEEN NO REPORTED REVISION PROCEDURE FOR THE PATIENT¿S RIGHT SIDE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6), 2007. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2007 TO IMPLANT A CABLE SYSTEM. THE STEM WAS REMOVED AND REPLACED. ADDITIONALLY, THE PATIENT WAS REVISED (B)(6), 2007 DUE TO RECURRENT DISLOCATION, INSTABILITY, AND LOOSENING. OPERATIVE (OP) NOTES REPORT SUBSIDENCE OF THE FEMORAL COMPONENT CAUSING SHORTENING AND INSTABILITY. REVISION OP NOTES ALSO REPORT PRESENCE OF CLEAR FLUID AND A LOOSE CUP. THE ACETABULAR COMPONENT, POLYETHYLENE LINER, FEMORAL COMPONENT, MODULAR HEAD, LATERAL STRUT GRAFT, AND ALL SIX CABLES WERE REMOVED AND REPLACED. ON (B)(6), 2008 DUE TO INSTABILITY AND A PERIPROSTHETIC FEMUR FRACTURE. THE POLYETHYLENE LINER AND MODULAR HEAD WERE REMOVED AND REPLACED. THE SURGEON ALSO IMPLANTED A TROCHANTER CLAW, BOLT AND CABLE SYSTEM. THEN, ON (B)(6), 2008, PATIENT WAS REVISED DUE TO INSTABILITY AND DISLOCATION. THE MODULAR HEAD WAS REMOVED AND REPLACED. OPERATIVE NOTES STATE THE PRESENCE OF A HEMATOMA AND THAT THE SURGEON PERFORMED IRRIGATION AND DEBRIDEMENT. ON (B)(6), 2008, THE PATIENT WAS REVISED DUE TO INFECTION. SURGEON PERFORMED IRRIGATION AND DEBRIDEMENT AND THE ACETABULAR CUP, POLYETHYLENE LINER AND MODULAR HEAD WERE REMOVED AND REPLACED. ALSO, THE FEMORAL STEM WAS REMOVED AND REPLACED WITH A COMPETITOR CEMENT SPACER MOLD. FINALLY, ON (B)(6), 2008 PATIENT UNDERWENT A STAGE TWO REVISION WHERE THE SURGEON REIMPLANTED TOTAL HIP COMPONENTS. THE MODULAR HEAD, ACETABULAR COMPONENT AND COMPETITOR CEMENT SPACER MOLD WERE REMOVED AND REPLACED. A REVIEW OF RADIOGRAPHIC IMAGES REVEALED THAT THE PATIENT IS BILATERAL. THEREFORE THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6), 2006. RADIOGRAPHS SHOW THE BIOMET CUP HAS MIGRATED VERTICALLY. ADDITIONAL INFORMATION FROM THE PATIENT'S LEGAL COUNSEL REPORTS PATIENT WAS REVISED ON THE RIGHT SIDE ON (B)(6), 2014 DUE TO PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY AND RANGE OF MOTION, SORENESS, DYSFUNCTION, AND ELEVATED METAL ION LEVELS, METAL POISONING, AND METALLOSIS. 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
    543723 M2A 1 PC SHELL 38MMX50MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 844370

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R