BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-RLOC LNR 10 DEG SZ 24/28MM

    MDR report key: 3222702 · Received July 12, 2013

    Report

    Report Number
    0001825034-2013-02660
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    February 4, 2014
    Report Date
    February 9, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK002379
    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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-02659 / 02662). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL AND CORRECTED INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CORRECTED DATA: FOLLOW UP REPORT 1825034-2013-02660-1 WAS SUBMITTED IN ERROR REPORTING THAT MEDWATCH 1825034-2013-02660 WAS A DUPLICATE OF 1825034-2014-06186.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP MEDWATCH IS BEING SUBMITTED TO REPORT THAT THIS MEDWATCH IS A DUPLICATE OF (B)(4), 1825034-2014-06186. THIS MEDWATCH 1825034-2013-02660 IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A M2A HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT ALLEGES PAIN, ELEVATED METAL ION LEVELS, NUMBNESS, AND THAT A REVISION IS RECOMMENDED. PATIENT FURTHER ALLEGES THEIR SURGEON NOTED AN UNSPECIFIED COMPLICATION WITH THE SCREW. REVIEW OF INVOICE HISTORY CONFIRMS TOTAL HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2005. NO FURTHER INFORMATION PROVIDED TO DATE. 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

    IT WAS REPORTED PATIENT UNDERWENT A M2A HIP ARTHOPLASTY. SUBSEQUENTLY, PATIENT ALLEGES PAIN, ELEVATED METAL ION LEVELS, NUMBNESS, AND THAT A REVISION IS RECOMMENDED. PATIENT FURTHER ALLEGES THEIR SURGEON NOTED AN UNSPECIFIED COMPLICATION WITH THE SCREW. REVIEW OF INVOICE HISTORY CONFIRMS TOTAL HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2005. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE THE LEFT HIP WAS REVISED ON (B)(6) 2014 DUE TO PAIN, ADVERSE SOFT TISSUE REACTION, AND ELEVATED CHROMIUM AND COBALT LEVELS. THE PATIENT'S OPERATIVE REPORT NOTED METALLOSIS, BLACKENED AMBER FLUID, AND OSTEOLYSIS. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323337 M2A-RLOC LNR 10 DEG SZ 24/28MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 142160

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization