BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD +6MM NK NO SKRT

    MDR report key: 3983572 · Received August 6, 2014

    Report

    Report Number
    0001825034-2014-06789
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    February 2, 2009
    Report Date
    October 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 2 STATES, ¿EARLY OR LATE POSTOPERATIVE, INFECTION, AND ALLERGIC REACTION.¿

    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 THIS TYPE OF EVENT CAN OCCUR: "MATERIAL SENSITIVITY REACTIONS", "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS", "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN", AND "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES". THIS REPORT IS NUMBER 2 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06788 / 06789).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2009 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, METALLOSIS, METAL POISONING, AND ELEVATED METAL ION LEVELS. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH SURGERY DATES AND THAT ALL COMPONENTS WERE REMOVED AND REPLACED WITH A CEMENT SPACER MOLD DURING THE REVISION SURGERY. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S MEDICAL RECORDS REVEALED THE (B)(6) 2009 SURGERY WAS DUE TO SYMPTOMS OF SEPSIS WITH SINUS FORMATION AND DRAINAGE. THE PATIENT'S OPERATIVE REPORT NOTED RESECTION OF THE FEMORAL/ACETABULAR COMPONENTS, AND PLACEMENT OF AN ANTIBIOTIC SPACER. ADDITIONAL INFORMATION IN PATIENT铠MEDICAL RECORDS REVEALED A (B)(6) 2011 SURGERY DUE TO INFECTION. THE PATIENT'S OPERATIVE REPORT NOTED HETEROTOPIC OSSIFICATION, SCAR TISSUE, AND REACTIVE TISSUE; WITH DEBRIDEMENT AND IRRIGATION PERFORMED AND AN ANTIBIOTIC SPACER EXCHANGED. FURTHER INFORMATION IN PATIENT'S MEDICAL RECORDS REVEALED AN (B)(6) 2013 SURGERY DUE TO INFECTION. THE PATIENT'S OPERATIVE REPORT NOTED SCAR TISSUE, TURBID FLUID, AND REACTIVE TISSUE; WITH DEBRIDEMENT PERFORMED AND AN ANTIBIOTIC SPACER EXCHANGED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2009 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, METALLOSIS, METAL POISONING, AND ELEVATED METAL ION LEVELS. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH SURGERY DATES AND THAT ALL COMPONENTS WERE REMOVED AND REPLACED WITH A CEMENT SPACER MOLD DURING THE REVISION SURGERY. 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
    461859 M2A 38MM MODULAR HEAD +6MM NK NO SKRT PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 274850

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R