BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP CEMENT FEMORAL HEAD RESUR 48M

    MDR report key: 3231144 · Received July 17, 2013

    Report

    Report Number
    0001825034-2013-02724
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    August 20, 2012
    Report Date
    June 17, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KXA
    PMA / PMN Number
    PK021799
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ 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 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02724 / 02726).

    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 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02724-1/02726-1).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF METALLOSIS, PAIN, LOSS OF RANGE OF MOTION, AND TISSUE/BONE DESTRUCTION. PATIENT¿S LEGAL COUNSEL ALLEGES THE PATIENT UNDERWENT A LEFT HIP REVISION IN 2010 AND A RIGHT HIP REVISION IN (B)(6) 2012. 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 BILATERAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF METALLOSIS, PAIN, LOSS OF RANGE OF MOTION, AND TISSUE/BONE DESTRUCTION. PATIENT¿S LEGAL COUNSEL ALLEGES THE PATIENT UNDERWENT A RIGHT HIP REVISION IN (B)(6) 2012. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE PATIENT UNDERWENT A RIGHT HIP FEMORAL HEAD RESURFACING PROCEDURE ON (B)(6) 2008. MEDICAL RECORDS INDICATE THE RIGHT HIP REVISION PROCEDURE ON (B)(6) 2012 WAS DUE TO LOOSENING OF THE RESURFACING HEAD. THE OPERATIVE NOTES CONFIRM THAT THE RESURFACING HEAD WAS REMOVED AND REPLACED WITH ACTIVE ARTICULATION LINER AND STEM. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S MEDICAL RECORDS INDICATE THAT THE LEFT TOTAL HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2008 AND WAS COMPETITOR PRODUCT. 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
    332741 RECAP CEMENT FEMORAL HEAD RESUR 48M PROSTHESIS, HIP KXA BIOMET ORTHOPEDICS N/A 226350

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R