BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD 48MM HEAD DIAMETER

    MDR report key: 2852193 · Received November 30, 2012

    Report

    Report Number
    0001825034-2012-02507
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    March 31, 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
    MT, 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." 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 5 OF 6 MDRS FILED FOR THE SAME PERSON (REFERENCE 1825034-2012-00491, 00493/00494, 02506/02508).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION AND BLOOD TEST RESULTS, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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." THIS REPORT IS NUMBER 5 OF 7 MDRS FILED FOR THE SAME PERSON (REFERENCE 1825034-2012-00491, 00493/00494 &02506 / 002508 & 2013-03868).

    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.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT UNDERWENT A RIGHT REVISION ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, METAL POISONING, METALLOSIS, LOSS OF RANGE OF MOTION AND BONE/TISSUE DESTRUCTION. INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS DUE TO PAIN, INSTABILITY, INFLAMMATORY CYSTIC LESION WITH FLUID, AND ELEVATED METAL IONS. OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER 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

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT UNDERWENT A RIGHT REVISION ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, METAL POISONING, METALLOSIS, LOSS OF RANGE OF MOTION AND BONE/TISSUE DESTRUCTION. INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS DUE TO PAIN, INSTABILITY, INFLAMMATORY CYSTIC LESION WITH FLUID, AND ELEVATED METAL IONS. OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. DURING REMOVAL OF THE CUP, OP NOTES REPORT UPON REMOVAL OF THE RIGHT ACETABULAR COMPONENT, CUP HAD BEEN SAWED AND A SMALL PIECE OF THE CUP THAT HAD FRACTURED FROM THE CUP WAS STILL EMBEDDED IN THE ANTERIOR ACETABULAR, WHICH WAS SUBSEQUENTLY REMOVED. PATIENT MEDICAL RECORDS STATE THE PATIENT IS ASYMPTOMATIC ON THE LEFT HIP AND NO REVISION HAS BEEN REPORTED TO DATE. 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 THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PAIN, POPPING AND ELEVATED COBALT CHROMIUM LEVELS. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2008. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. 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
    1 M2A-MAGNUM MODULAR HEAD 48MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 433400

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R