BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP FEM HEAD COCR CEMENTED DIA44MM

    MDR report key: 5125379 · Received October 2, 2015

    Report

    Report Number
    3002806535-2015-04033
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    December 7, 2015
    Report Date
    September 15, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KXA
    PMA / PMN Number
    PK021799
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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. (B)(4). 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 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 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 3002806535-2015-04033-1 / 3002806535-2015-04034-1).

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. 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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: INITIAL REPORTER - UNKNOWN. 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." AND NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." THIS REPORT IS NUMBER 1 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 3002806535 -2015 -04033 / 04034).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY NINETEEN MONTHS POST-IMPLANTATION DUE TO ALLEGATIONS OF SYMPTOMS OF METALLOSIS, METAL ALLERGIES, PAIN, PSEUDOTUMOR, METAL POISONING, WEAR OF THE DEVICE, AND ELEVATED METAL IONS. ALL PRODUCTS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS. THE PATIENT'S ATTORNEY ALSO ALLEGES THE PATIENT EXPERIENCED HEARING ISSUES, PALPITATIONS, LIVER ISSUES, STOMACH ACHES, NAUSEA, FREQUENT VOMITING, DIARRHEA WITH BLOOD IN THE STOOL, HEADACHES AND HYPERTENSION. 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

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP RESURFACING PROCEDURE ON (B)(6) 2014. IT WAS REPORTED PATIENT IS EXPERIENCING SYMPTOMS OF METALLOSIS AND METAL ALLERGIES. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654966 RECAP FEM HEAD COCR CEMENTED DIA44MM PROSTHESIS, HIP KXA BIOMET UK LTD. N/A 909572

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R