BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD COMPONENT 32MM

    MDR report key: 4478645 · Received February 3, 2015

    Report

    Report Number
    0001825034-2015-00449
    Event Type
    Injury
    Date Received
    February 3, 2015
    Date of Event
    January 26, 2015
    Report Date
    January 23, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWY
    PMA / PMN Number
    PK003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "MATERIAL SENSITIVITY REACTIONS." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-00448 / 00449).

    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. (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 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-00448 / 00449 AND 2017-00083).

    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. CONCOMITANT MEDICAL PRODUCTS: PN: 10-104052, LN: 382360, M2A-T M/H RAD 2HL SHL. PN: 162311, LN: 646440, BI-METRIC POROUS FMRL.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY 12 YEARS POST-IMPLANTATION DUE TO LEFT HIP PAIN, DECREASED RANGE OF MOTION, AND REACTION TO METAL DEBRIS. DURING THE REVISION, WELL-FIXED FEMORAL AND ACETABULAR COMPONENTS, SIGNIFICANT EROSION OF THE GREATER TROCHANTER, AND CORROSION AT THE HEAD-TAPER JUNCTION WERE NOTED. ALL COMPONENTS WERE REMOVED AND REPLACED AND A POLY BEARING WAS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2015 DUE TO A REACTION TO METAL DEBRIS. ALL COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79145 M2A MODULAR HEAD COMPONENT 32MM PROSTHESIS, HIP KWY BIOMET ORTHOPEDICS N/A 139580

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R