BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 48MM

    MDR report key: 3782156 · Received April 30, 2014

    Report

    Report Number
    0001825034-2014-03453
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    September 4, 2012
    Report Date
    April 26, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. REVIEW OF THE DEVICE WAS UNABLE TO CONFIRM THE REPORTED COMPLAINT. DURING EXAMINATION SCRATCHES AND WEAR MARKS WERE NOTED ON THE MODULAR HEAD. A CONCLUSIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED.

    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.

    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 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.¿ 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 EVENT (REFERENCE 1825034-2014-03452/03455).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A BILATERAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, LOSS OF HEARING, LOSS OF BALANCE, PSEUDOTUMORS, METAL WEAR, METAL POISONING, SCAR TISSUE, FLUID COLLECTIONS, SOFT TISSUE CHANGES AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT UNDERWENT A BILATERAL REVISION PROCEDURE ON (B)(6) 2012. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATES AND INDICATES THAT THE MODULAR HEAD AND TAPER ADAPTER, IN BOTH HIPS, WERE 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 PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY PROCEDURES ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, LOSS OF HEARING, LOSS OF BALANCE, PSEUDOTUMORS, METAL WEAR, METAL POISONING, SCAR TISSUE, FLUID COLLECTIONS, SOFT TISSUE CHANGES AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT UNDERWENT BILATERAL REVISION PROCEDURES ON (B)(6) 2012. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATES AND INDICATES THAT THE MODULAR HEADS AND TAPER ADAPTERS WERE REMOVED AND REPLACED IN EACH HIP. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT NOTED PATIENT UNDERWENT A BILATERAL HIP REVISION ON (B)(6) 2012 DUE TO FLUID COLLECTIONS AND SOFT TISSUE CHANGES. REVISION OPERATIVE REPORT NOTED THE PRESENCE OF FLUID AND FIBROSIS. THE CUP WAS WELL FIXED. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED IN BOTH REVISION PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259699 M2A-MAGNUM MOD HD SZ 48MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 154410

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R