BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP CEMENT FMRL HD RESUR 50M

    MDR report key: 3800635 · Received May 8, 2014

    Report

    Report Number
    0001825034-2014-03708
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    July 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK021799
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    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 1 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 OF THE FEMORAL NECK AND/OR POSTOPERATIVE PAIN.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-03707/03710).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT HIP RESURFACING PROCEDURE ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, LACK OF MOBILITY AND DAMAGE TO SURROUNDING BONE/TISSUE. AND A LEFT HIP RESURFACING PROCEDURE ON (B)(6) 2007. PATIENT'S LEGAL COUNSEL REPORTED PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2012. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE INITIAL RIGHT HIP RESURFACING SURGERY DATE OF (B)(6) 2008. REVIEW OF INVOICE HISTORY FOUND AN INVOICE FOR AN INITIAL HIP RESURFACING PROCEDURE ON (B)(6) 2007, WHICH WAS DETERMINED THROUGH FOLLOW UP TO HAVE BEEN FOR THE LEFT HIP. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT OPERATIVE (OP) NOTES DATED (B)(6) 2011 REPORTS PATIENT WAS REVISED ON THE RIGHT HIP DUE TO PAIN, GAIT ABNORMALITY, AND A LOOSE CUP. REVISION OP REPORT NOTES THE PRESENCE OF FIBROTIC AND SCARRED BURSA, SCAR TISSUE PREVENTING MOBILITY ABOUT THE FEMUR, CALCIFIED LABRUM AND METALLOSIS AROUND THE CUP. OP REPORT FURTHER NOTES THAT THE CUP WAS IN A VERTICAL POSITION. THE CUP AND HEAD WERE REMOVED AND CONVERTED TO A TOTAL HIP REPLACEMENT.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT HIP RESURFACING PROCEDURE ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, LACK OF MOBILITY AND DAMAGE TO SURROUNDING BONE/TISSUE. AND A LEFT HIP RESURFACING PROCEDURE ON (B)(6) 2007. PATIENT'S LEGAL COUNSEL REPORTED PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2012. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE INITIAL RIGHT HIP RESURFACING SURGERY DATE OF (B)(6) 2008, BUT COULD NOT CONFIRM THE DATE OF THE REVISION SURGERY. REVIEW OF INVOICE HISTORY FOUND AN INVOICE FOR AN INITIAL HIP RESURFACING PROCEDURE ON (B)(6) 2007, WHICH WAS DETERMINED THROUGH FOLLOW UP TO HAVE BEEN FOR THE LEFT HIP. AN ADDITIONAL INVOICE WAS FOUND FOR A REVISION PROCEDURE THAT WAS PERFORMED ON (B)(6) 2011 WHERE A TOTAL HIP SYSTEM WAS IMPLANTED. IT IS NOT KNOWN WHETHER OR NOT THIS REVISION PROCEDURE TO CONVERT TO A TOTAL HIP WAS PERFORMED ON THE LEFT OR THE RIGHT HIP. 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
    278621 RECAP CEMENT FMRL HD RESUR 50M PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 945410

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R