BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SZ 52MM

    MDR report key: 3052067 · Received April 11, 2013

    Report

    Report Number
    0001825034-2013-00920
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    December 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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: "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 6 OF 6 MDRS FILED FOR THE SAME PATIENT(REFERENCE 1825034-2013-00915 / 00920). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THESE TYPES OF EVENTS CAN OCCUR UNDER POSSIBLE ADVERSE EFFECTS: MATERIAL SENSITIVITY REACTIONS. INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. THE PATIENT FURTHER ALLEGES PAIN, POPPING AND SYMPTOMS OF ELEVATED METAL IONS. A REVIEW OF INVOICE HISTORY CONFIRMS BOTH PRIMARY SURGERY DATES. THERE HAS BEEN NO REPORTED REVISION TO DATE. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. THE PATIENT FURTHER ALLEGES PAIN, POPPING AND SYMPTOMS OF ELEVATED METAL IONS. A REVIEW OF INVOICE HISTORY CONFIRMS BOTH PRIMARY SURGERY DATES. THERE HAS BEEN NO REPORTED REVISION TO DATE. ADDITIONAL INFORMATION FROM LEGAL COUNSEL FOR THE PATIENT FURTHER REPORTS PATIENT ALLEGATIONS OF SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, FEMORAL NERVE DAMAGE, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY AND METALLOSIS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. THE PATIENT FURTHER ALLEGES PAIN, POPPING AND SYMPTOMS OF ELEVATED METAL IONS. A REVIEW OF INVOICE HISTORY CONFIRMS BOTH PRIMARY SURGERY DATES. THERE HAS BEEN NO REPORTED REVISION TO DATE. ADDITIONAL INFORMATION FROM LEGAL COUNSEL FOR THE PATIENT FURTHER REPORTS PATIENT ALLEGATIONS OF SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, FEMORAL NERVE DAMAGE, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY AND METALLOSIS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS NOTED THAT ON (B)(6) 2014 PATIENT'S BLOOD WAS TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154510 M2A-MAGNUM MODULAR HEAD SZ 52MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 164240

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R