BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MOD HD 38

    MDR report key: 3061450 · Received April 16, 2013

    Report

    Report Number
    0001825034-2013-00999
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    May 11, 2010
    Report Date
    January 21, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00999 & 01002).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE REASON FOR THE REVISION PROCEDURE, 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 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 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00999-1, 01002-1 & 02295 / 02296).

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN A REVIEW OF OPERATIVE MEDICAL RECORDS CONFIRMS THE LEFT HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2003 AND THE RIGHT HIP ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, ADDITIONAL INFORMATION PROVIDED IN MEDICAL RECORDS STATES PATIENT ALLEGES PAIN AND SWELLING OF THE LEFT LEG. PATIENT ALLEGES REVISION OF UNKNOWN SIDE ON AN UNKNOWN DATE. 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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN A REVIEW OF OPERATIVE MEDICAL RECORDS CONFIRMS THE LEFT HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2003 AND THE RIGHT HIP ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, ADDITIONAL INFORMATION PROVIDED IN MEDICAL RECORDS STATES PATIENT ALLEGES PAIN AND SWELLING OF THE LEFT LEG. PATIENT ALLEGES REVISION OF UNKNOWN SIDE ON AN UNKNOWN DATE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE TOOK PLACE ON (B)(6) 2010 ON THE LEFT HIP AND WAS DUE TO ELEVATED METAL IONS, METAL DEBRIS REACTION AND SOFT TISSUE LESIONS. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. THERE HAS BEEN NO REPORTED REVISION PROCEDURE ON THE RIGHT HIP. 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 PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN A REVIEW OF OPERATIVE MEDICAL RECORDS CONFIRMS THE LEFT HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2003 AND THE RIGHT HIP ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, ADDITIONAL INFORMATION PROVIDED IN MEDICAL RECORDS STATES PATIENT ALLEGES PAIN AND SWELLING OF THE LEFT LEG. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE TOOK PLACE ON (B)(6) 2010 ON THE LEFT HIP AND WAS DUE TO ELEVATED METAL IONS, METAL DEBRIS REACTION AND SOFT TISSUE LESIONS. THE OPERATIVE (OP) NOTES CONFIRM THAT THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. THERE HAS BEEN NO REPORTED REVISION PROCEDURE ON THE RIGHT HIP. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT REVISION OP REPORT DATED (B)(6) 2010 NOTES OCCLUSION OF THE FEMORAL VEIN AND LEG SWELLING; CYSTIC LESIONS; BROWN, TEA-LIKE LIQUID; BROWN-STAINED ACETABULAR LINING; IRRITATED, GRANULAR-TYPE LINING; AND BONE DEFICIENCY BEHIND THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161921 M2A MOD HD 38 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 669160

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R