BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 50MM

    MDR report key: 3813016 · Received May 15, 2014

    Report

    Report Number
    0001825034-2014-04065
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    September 30, 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
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. 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." NUMBER 15, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 4 OF 6 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01687, 2014-04063 / 04065, 2015-00532 AND 2016-04310).

    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. THIS REPORT IS NUMBER 4 OF 5 MDR'S FILED FOR THE SAME PERSON (REFERENCE 1825034-2013-01687 & 2014-04063 / 04065 & 2015-00532).

    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: "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "MATERIAL SENSITIVITY REACTIONS.¿ AND "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 4 OF 4 MDRS FILED FOR THE SAME PERSON (REFERENCE 1825034-2013-01687 & 2014-04063/-04064/-04065).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO ALLEGED PAIN. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A BIOMET HEAD AND COMPETITOR CUP. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT¿S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. LEGAL DOCUMENT FURTHER ALLEGES A RIGHT HIP REVISION OCCURRED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, METAL POISONING, METALLOSIS, LOSS OF RANGE OF MOTION AND ELEVATED METAL ION LEVELS.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT EXPERIENCED ELEVATED METAL ION LEVELS APPROXIMATELY SIX YEARS POST-IMPLANTATION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE NOTES REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY NINE YEARS POST-IMPLANTATION DUE TO PAIN. DURING THE PROCEDURE, SCAR TISSUE, TRUNNIONOSIS AND BONE LOSS WERE NOTED. THE HEAD AND CUP WERE REMOVED AND REPLACED. A LEGACY ZIMMER CUP AND LINER WERE USED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO ALLEGED PAIN. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A BIOMET HEAD AND COMPETITOR CUP. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. LEGAL DOCUMENT FURTHER ALLEGES A RIGHT HIP REVISION OCCURRED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, METAL POISONING, METALLOSIS, LOSS OF RANGE OF MOTION AND ELEVATED METAL ION LEVELS. ADDITIONAL INFORMATION RECEIVED IN REVISION OPERATIVE REPORT NOTED PRESENCE OF CLEAR SEROUS FLUID, METALLIC STAINED TISSUE, METAL CORROSION AT THE TAPER AND BROWNISH TISSUE CONSISTENT WITH METALLOSIS AROUND THE ACETABULUM. THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED WITH A COMPETITOR CUP AND BIOMET HEAD AND TAPER ADAPTER. 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
    290392 M2A-MAGNUM MOD HD SZ 50MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 327270

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization