BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 48ODX42ID

    MDR report key: 5736612 · Received June 20, 2016

    Report

    Report Number
    0001825034-2016-02142
    Event Type
    Injury
    Date Received
    June 20, 2016
    Date of Event
    August 20, 2014
    Report Date
    May 23, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." (B)(4) THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-02141 / 02142). ADDITIONAL EVENT FOR THIS PATIENT REPORTED ON MEDWATCH NUMBERS 1825034-2016-02139 / 02140. NOT RETURNED BY ATTORNEY.

    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. MEDICAL PRODUCT - BIOMET M2A MAGNUM TAPER ADAPTER, CATALOG#: 139254, LOT#: 911030; BIOMET. FEMORAL STEM, CATALOG#: X180313, LOT#: 991560. (B)(4). THIS REPORT IS NUMBER 4 OF 7 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-2139 / 02142 & 04718 / 04720).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO ALLEGED PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, DISLOCATIONS, METALLOSIS, AND METAL DEBRIS. REVIEW OF INVOICE HISTORY CONFIRMS THE MODULAR HEAD WAS REMOVED AND REPLACED. 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 A RIGHT HIP REVISION PROCEDURE APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO ALLEGED PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, DISLOCATIONS, METALLOSIS, AND METAL DEBRIS. REVIEW OF INVOICE HISTORY CONFIRMS THE MODULAR HEAD WAS REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. IT WAS REPORTED IN OPERATIVE REPORT RECEIVED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO PAIN, AMBULATION DIFFICULTIES, INSTABILITY AND ELEVATED METAL ION LEVELS. DURING THE PROCEDURE, FLUID COLLECTIONS, LYSIS AND BONE EROSION WERE NOTED. THE FEMORAL HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. A LEGACY ZIMMER CUP AND LINER WERE USED TO COMPLETE THE PROCEDURE. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT PREVIOUS REDUCTIONS FOR RIGHT HIP DISLOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391018 M2A-MAGNUM PF CUP 48ODX42ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 328920

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R