BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 50MM

    MDR report key: 3963564 · Received July 29, 2014

    Report

    Report Number
    0001825034-2014-06506
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 14, 2014
    Report Date
    August 13, 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
    MD, 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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 11 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE, INCLUDING EARLY OR LATE FRACTURE OF THE FEMORAL NECK DUE TO NOTCHING DURING SURGERY AND/OR POSTOPERATIVE PAIN OR DELAYED HEALING." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06505 & 06506).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2005 AND A RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE WITH UNKNOWN PRODUCT. SUBSEQUENTLY, PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE ON (B)(6) 2008 DUE TO AN UNKNOWN REASON. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A TOTAL HIP SYSTEM. PATIENT WAS FURTHER REVISED ON AN UNKNOWN SIDE ON (B)(6) 2011 DUE TO AN UNKNOWN REASON. THE MODULAR HEAD AND FEMORAL STEM WERE (B)(6) 2014 DUE TO PAIN. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A BIOMET HEAD AND COMPETITOR CUP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2005 AND LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE OF THE RIGHT HIP ON (B)(6) 2011 DUE TO AN UNKNOWN REASON. DURING THE PROCEDURE, THE MODULAR HEAD WAS REMOVED AND REPLACED. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE OF THE LEFT HIP ON (B)(6) 2011 WHERE ALL COMPONENTS WERE REMOVED AND REPLACED. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATES AND WHICH COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442140 M2A-MAGNUM MOD HD SZ 50MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 623570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R