BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD 52MM HEAD DIAMETER

    MDR report key: 5917228 · Received August 31, 2016

    Report

    Report Number
    0001825034-2016-03389
    Event Type
    Injury
    Date Received
    August 31, 2016
    Date of Event
    January 15, 2015
    Report Date
    October 6, 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
    FL, 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 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE 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 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03388 / 03389).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL AND CORRECTED INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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. CONCOMITANT MEDICAL PRODUCTS - BIOMET M2A MAGNUM ACETABULAR CUP CATALOG#: US157858 LOT#: 280720, BIOMET M2A MAGNUM TAPER ADAPTER CATALOG#: 139266 LOT#: 021580, BIOMET MALLORYHEAD FEMORAL STEM CATALOG#: 11-104115 LOT#: 231260. (B)(4). 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 11 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES."

    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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY NINE YEARS POST-IMPLANTATION DUE TO ALLEGED PAIN, DISCOMFORT, SORENESS, METAL POISONING, METALLOSIS, AND METAL DEBRIS. THE HEAD WAS REMOVED AND REPLACED AND A POLY HIP BEARING WAS IMPLANTED. 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 A RIGHT HIP REVISION PROCEDURE APPROXIMATELY NINE YEARS POST-IMPLANTATION DUE TO ALLEGED PAIN, DISCOMFORT, SORENESS, METAL POISONING, METALLOSIS, AND METAL DEBRIS. THE HEAD WAS REMOVED AND REPLACED AND A POLY HIP BEARING WAS IMPLANTED. 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 NINE YEARS POST-IMPLANTATION DUE TO PAIN AND WEAR. DURING THE PROCEDURE, THE FEMORAL HEAD WAS REMOVED AND REPLACED. AN ACTIVE ARTICULATION BEARING WAS ALSO IMPLANTED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570526 M2A MAGNUM MODULAR HEAD 52MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 724470

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R