BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX56MM CUP

    MDR report key: 3893872 · Received June 25, 2014

    Report

    Report Number
    0001825034-2014-05756
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    December 29, 2015
    Report Date
    April 20, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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.

    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.

    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 THESE TYPES OF EVENTS CAN OCCUR UNDER POSSIBLE ADVERSE EFFECTS: INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN. METAL ON METAL ARTICULATING SURFACES HAVE LIMITED CLINICAL HISTORY. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN THE PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05755 / 05756).

    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 BASED ON ALLEGATIONS SET FORTH IN THE PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05755 / 05756).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, THE PATIENT ALLEGES PAIN, NUMBNESS, AND ELEVATED METAL ION LEVELS. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN THE PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S MEDICAL RECORDS REVEALED MRI OF THE RIGHT HIP WAS PERFORMED ON (B)(6) 2014. ADDITIONAL INFORMATION IN PATIENT MEDICAL RECORDS NOTE THAT ON (B)(6) 2010, (B)(6) 2014, AND (B)(6) 2014 PATIENT'S BLOOD WAS TESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, THE PATIENT ALLEGES PAIN, NUMBNESS, AND ELEVATED METAL ION LEVELS. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN THE PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, THE PATIENT ALLEGES PAIN, NUMBNESS, AND ELEVATED METAL ION LEVELS. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN THE PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN CLINICAL NOTES ALLEGEDLY INDICATE PATIENT EXPERIENCING PAIN IN JOINT IN MULTIPLE SITES INCLUDING THE PELVIC REGION AND THIGH, OTHER MALAISE AND FATIGUE, HYPOTHYROIDISM AND HYPERHIDROSIS. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THE PATIENT WAS REVISED ON (B)(6) 2015. PATIENT REPORTED INFLAMMATION AROUND THE JOINT WAS NOTED DURING THE PROCEDURE. THE HEAD AND CUP WERE REMOVED AND REPLACED WITH LEGACY BIOMET HEAD, TAPER AND LEGACY ZIMMER CUP AND LINER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, THE PATIENT ALLEGES PAIN, NUMBNESS, AND ELEVATED METAL ION LEVELS. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN THE PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN CLINICAL NOTES ALLEGEDLY INDICATE PATIENT EXPERIENCING PAIN IN JOINT IN MULTIPLE SITES INCLUDING THE PELVIC REGION AND THIGH, OTHER MALAISE AND FATIGUE, HYPOTHYROIDISM AND HYPERHIDROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371132 M2A 38MMX56MM CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 283100

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R