BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 54MM

    MDR report key: 3021527 · Received March 26, 2013

    Report

    Report Number
    0001825034-2013-00740
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    June 18, 2013
    Report Date
    January 14, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00739 / 00740).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY PATIENT'S BLOOD TEST RESULTS.

    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 INFORMATION RECEIVED CONFIRMS THAT A REVISION PROCEDURE OCCURRED ON (B)(6) 2013.

    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

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, IT IS REPORTED THAT A REVISION IS RECOMMENDED BY SURGEON ALLEGEDLY DUE TO PAIN, CLICKING AND GRINDING, AND ELEVATED METAL IONS.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 ALLEGEDLY DUE TO PAIN, CLICKING AND GRINDING, AND ELEVATED METAL IONS. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 ALLEGEDLY DUE TO PAIN, CLICKING AND GRINDING, AND ELEVATED METAL IONS. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S REVISION MEDICAL RECORDS NOTED THE REVISION WAS DUE TO PAIN AND ELEVATED METAL ION LEVELS. MEDICAL RECORDS FURTHER NOTED THE PRESENCE OF CORROSION AT MORSE TAPER. THE MODULAR HEAD WAS REMOVED AND REPLACED. THE ACETABULAR CUP WAS REPLACED WITH A COMPETITOR'S PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123252 M2A-38 CUP NON FLARED SZ 54MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R