BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 58MM

    MDR report key: 3693787 · Received March 21, 2014

    Report

    Report Number
    0001825034-2014-02071
    Event Type
    Injury
    Date Received
    March 21, 2014
    Report Date
    August 6, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. 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 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-02071 & 02072).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS ENROLLED IN (B)(6). IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. DURING POST OPERATIVE MONITORING AND TESTING, MALPOSITIONED CUP, SOFT TISSUE ABNORMALITIES, FLUID WAS NOTED. THE FLUID ON THE POSTERIOR LATERAL QUADRANT OF THE LEFT HIP MEASURED 10.8X22.8X3.6MM. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP TESTING. ADDITIONAL INFORMATION RECEIVED INDICATES PATIENT REPORTED PAIN, POPPING, LIMPING, AND DECREASED RANGE OF MOTION DURING FOLLOW UP TESTING. PATIENT ALSO REPORTS EXPERIENCING MILD/OCCASIONAL PAIN, AS WELL AS ATROPHY OF THE LEFT HIP/LEG AND CALF MUSCLE AFTER ONE YEAR. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS ENROLLED IN A (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. DURING POST OPERATIVE MONITORING AND TESTING, ACETABULAR CUP MALPOSITIONING AND SOFT TISSUE ABNORMALITIES WERE NOTED. THE FLUID ON THE POSTERIOR LATERAL QUADRANT LEFT HIP MEASURED 10.8X22.8X3.6 MM. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP TESTING, THERE WERE NO SYMPTOMS REPORTED BY THE PATIENT. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169620 M2A-38 CUP NON FLARED SZ 58MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 567860

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention