BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNUM TRISPIKE CUP 64ODX58ID

    MDR report key: 3901605 · Received June 30, 2014

    Report

    Report Number
    0001825034-2014-05731
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    September 23, 2013
    Report Date
    May 13, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK062995
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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: PRODUCT IDENTIFICATION/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.

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY." "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS NUMBER 1 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05731 AND 1825034-2015-02436 & 02437 & 02438 & 02439).

    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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL FURTHER REPORTS THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, AND METALLOSIS. ADDITIONALLY, LEGAL COUNSEL FOR PATIENT REPORTS AN ALVAL-TYPE LESION, MILD TAPER CORROSION ON THE STEM, SCAR TISSUE AND SWELLING OF THE SYNOVIAL LINING, AND MUSCLE AND SOFT TISSUE LAXITY WERE ALLEGEDLY NOTED DURING THE REVISION PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT'S REVISION OPERATIVE REPORT CONFIRMS PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2013 DUE TO ASEPTIC LOOSENING, PAIN, AND CLICKING NOISE. OPERATIVE REPORT FURTHER NOTED BURST OF SEROUS FLUID, ALVAL TYPE LESION WITH PSEUDOSYNOVIAL MEMBRANE, TAPER CORROSION ON STEM, AND SCAR AND INFLAMED HYPERTROPHIC SYNOVIUM ON THE ACETABULUM. THE MODULAR HEAD, TAPER ADAPTER, AND ACETABULAR CUP WERE REMOVED AND REPLACED AND AN ACETABULAR LINER WAS IMPLANTED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, AND METALLOSIS. LEGAL COUNSEL FOR PATIENT REPORTS AN ALVAL-TYPE LESION, MILD TAPER CORROSION ON THE STEM, SCAR TISSUE AND SWELLING OF THE SYNOVIAL LINING, AND MUSCLE AND SOFT TISSUE LAXITY WERE ALLEGEDLY NOTED DURING THE REVISION PROCEDURE. 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 THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL FURTHER REPORTS THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, AND METALLOSIS. ADDITIONALLY, LEGAL COUNSEL FOR PATIENT REPORTS AN ALVAL-TYPE LESION, MILD TAPER CORROSION ON THE STEM, SCAR TISSUE AND SWELLING OF THE SYNOVIAL LINING, AND MUSCLE AND SOFT TISSUE LAXITY WERE ALLEGEDLY NOTED DURING THE REVISION PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT'S REVISION OPERATIVE REPORT CONFIRMS PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2013 DUE TO ASEPTIC LOOSENING, PAIN, AND CLICKING NOISE. OPERATIVE REPORT FURTHER NOTED BURST OF SEROUS FLUID, ALVAL TYPE LESION WITH PSEUDOSYNOVIAL MEMBRANE, TAPER CORROSION ON STEM, AND SCAR AND INFLAMED HYPERTROPHIC SYNOVIUM ON THE ACETABULUM. THE MODULAR HEAD, TAPER ADAPTER, AND ACETABULAR CUP WERE REMOVED AND REPLACED AND AN ACETABULAR LINER WAS IMPLANTED. ADDITIONALLY, POST OPERATIVE X-RAYS SHOWED THE PATIENT HAD SUPERIOR ANTERIOR SUBLUXATION OF THE FEMORAL HEAD, THEREFORE A CLOSED REDUCTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379250 MAGNUM TRISPIKE CUP 64ODX58ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 354620

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R