BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP CEMENTED FEMORAL HEAD

    MDR report key: 2864425 · Received December 10, 2012

    Report

    Report Number
    0001825034-2012-02547
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    May 13, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KXA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 1 OF 7 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-02547 / 002549 & 02567, 2014-05282 / 05284).

    Additional Manufacturer Narrative · 1

    EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - 2010. EXPIRATION DATE - UNKNOWN. DATE EXPLANTED - 2010. MANUFACTURE DATE - UNKNOWN. 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 MDRS FILED FOR THE SAME PERSON (REFERENCE 1825034-2012-02547 / 002549 & 02567).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT RIGHT HIP RESURFACING ON (B)(6) 2007 AND A LEFT HIP RESURFACING ON (B)(6) 2008. SUBSEQUENTLY, PATIENT'S RIGHT HIP WAS REVISED TO A TOTAL HIP ARTHROPLASTY IN 2009 DUE TO AN UNKNOWN REASON. THE RECAP FEMORAL HEAD WAS REMOVED AND REPLACED WITH A M2A HEAD AND TAPERLOC FEMORAL STEM. IN 2010, PATIENT'S LEFT HIP WAS REVISED TO A TOTAL HIP ARTHROPLASTY DUE TO AN UNKNOWN REASON. THE RECAP FEMORAL HEAD WAS REMOVED AND REPLACED WITH A M2A HEAD AND TAPERLOC FEMORAL STEM. FURTHER, PATIENT UNDERWENT A LEFT HIP REVISION IN 2010 AND A RIGHT HIP REVISION IN 2011 TO REMOVE THE M2A SYSTEMS ALLEGEDLY DUE TO DAMAGE TO BONE AND TISSUE, PAIN, SWELLING, LACK OF MOBILITY, IMPAIRMENT AND INFLAMMATION. NO FURTHER INFORMATION HAS BEEN PROVIDED 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

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT RIGHT HIP RESURFACING ON (B)(6), 2007 AND A LEFT HIP RESURFACING ON (B)(6), 2008. SUBSEQUENTLY, PATIENT'S RIGHT HIP WAS REVISED TO A TOTAL HIP ARTHROPLASTY IN 2009 DUE TO AN UNKNOWN REASON. THE RECAP FEMORAL HEAD WAS REMOVED AND REPLACED WITH A M2A HEAD AND TAPERLOC FEMORAL STEM. IN 2010 PATIENT'S LEFT HIP WAS REVISED TO A TOTAL HIP ARTHROPLASTY DUE TO AN UNKNOWN REASON. THE RECAP FEMORAL HEAD WAS REMOVED AND REPLACED WITH A M2A HEAD AND TAPERLOC FEMORAL STEM. FURTHER, PATIENT UNDERWENT A LEFT HIP REVISION IN 2010 AND A RIGHT HIP REVISION IN 2011 TO REMOVE THE M2A SYSTEMS ALLEGEDLY DUE TO DAMAGE TO BONE AND TISSUE, PAIN, SWELLING, LACK OF MOBILITY, IMPAIRMENT AND INFLAMMATION. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE THAT THE FIRST LEFT HIP REVISION PERFORMED ON (B)(6) 2010 NOTED YELLOW-TINGED CLEAR FLUID AND SLIGHT BONE SOFTENING; SECOND LEFT HIP REVISION PERFORMED ON (B)(6) 2010 NOTED YELLOW-TINGED CLEAR FLUID AND INFLAMMATORY TISSUE. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE THAT THE FIRST RIGHT REVISION PERFORMED ON (B)(6) 2009 NOTED YELLOW-TINGED CLEAR FLUID, NECROSIS AND OSTEOLYSIS; SECOND RIGHT REVISION PERFORMED ON (B)(6) 2011 NOTED BURSITIS, A TROCHANTERIC SPUR AND BROWN DISCOLORATION OF THE SYNOVIUM. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS NOTED THAT ON (B)(6) 2010 AND (B)(6), 2011 PATIENT'S BLOOD WAS TESTED. 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
    1 RECAP CEMENTED FEMORAL HEAD PROSTHESIS, HIP KXA BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R