BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM M2A MOD HEAD -3MM NK

    MDR report key: 5514505 · Received March 21, 2016

    Report

    Report Number
    0001825034-2016-00949
    Event Type
    Injury
    Date Received
    March 21, 2016
    Report Date
    June 28, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-00473-1 / 00525-1 / 00949). PRODUCT LOCATION UNKNOWN.

    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 NUMBER 3 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-00473-1 & 00525-1 & 00949 & 02809/ 02811).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2006. THE PATIENT UNDERWENT AN INITIAL TOTAL LEFT HIP ARTHROPLASTY ON AN UNKNOWN DATE IN 2007. SUBSEQUENTLY, THE PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2014 DUE TO A PSEUDOTUMOR LOCATED AT THE ILIOPSOAS MUSCLE. METALLIC DEBRIS AND FOREIGN BODY GRANULOMAS WERE ALSO NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY 8 YEARS POST-IMPLANTATION DUE TO A PSEUDOTUMOR LOCATED AT THE ILIOPSOAS MUSCLE. METALLIC DEBRIS AND FOREIGN BODY GRANULOMAS WERE ALSO NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169320 28MM M2A MOD HEAD -3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 881530

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R