BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A RINGLOC LINER 28MM 10DEGREE SIZE 23

    MDR report key: 4181257 · Received October 17, 2014

    Report

    Report Number
    3002806535-2014-00235
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    February 18, 2013
    Report Date
    October 23, 2015
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK002379
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT HAS BEEN RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. DATE OF EVENT - (B)(6) 2013 (EXACT DATE UNKNOWN), EXPIRATION DATE - UNKNOWN, EXPLANT DATE - (B)(6) 2013 (EXACT DATE UNKNOWN), MANUFACTURE DATE - UNKNOWN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE REVISION SURGERY ON THE RIGHT HIP WAS PERFORMED ON (B)(6) 2013. THE PATIENT ALSO HAD A LEFT HIP SURGERY ON (B)(6) 2004. A LEFT REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PAIN, TISSUE AND BONE DAMAGE, AND ELEVATED METAL ION LEVELS. ITEM AND LOT NUMBERS HAVE BEEN RECEIVED, BUT THERE IS NO INDICATION WHAT SURGERY THESE NUMBERS CORRELATE TO. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP REPLACEMENT ON (B)(6) 2003. REVISION PROCEDURE WAS PERFORMED IN (B)(6) 2013 DUE TO PAIN, TISSUE AND BONE DAMAGE, AND ELEVATED METAL ION LEVELS. NO FURTHER INFORMATION HAS BEEN RECEIVED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S NOTICE AND THE ALLEGATIONS THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP REPLACEMENT ON (B)(6) 2003. REVISION PROCEDURE WAS PERFORMED IN (B)(6) 2013 DUE TO PAIN, TISSUE AND BONE DAMAGE, AND ELEVATED METAL ION LEVELS. NO FURTHER INFORMATION HAS BEEN RECEIVED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S NOTICE AND THE ALLEGATIONS THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE REVISION SURGERY ON THE RIGHT HIP WAS PERFORMED ON (B)(6) 2013. THE PATIENT ALSO HAD A LEFT HIP SURGERY ON (B)(6) 2004. A LEFT REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PAIN, TISSUE AND BONE DAMAGE, AND ELEVATED METAL ION LEVELS. ITEM AND LOT NUMBERS HAVE BEEN RECEIVED, BUT THERE IS NO INDICATION WHAT SURGERY THESE NUMBERS CORRELATE TO. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2013 DUE TO UNKNOWN REASONS. PATIENT FURTHER ALLEGES TISSUE DAMAGE AND RECOVERY ISSUES. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. REVIEW OF THE MEDICAL RECORDS FOR THE RIGHT HIP NOTE ELEVATED ION LEVELS, TISSUE DAMAGE, BONE DESTRUCTION, AND METAL EMBEDDED IN THE TISSUE. REVIEW OF MEDICAL RECORDS FOR THE LEFT HIP NOTED OSTEOLYSIS AND ADVERSE REACTIONS TO METAL DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660807 M2A RINGLOC LINER 28MM 10DEGREE SIZE 23 PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 551897

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R