BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD -3MM NK

    MDR report key: 3689178 · Received March 19, 2014

    Report

    Report Number
    0001825034-2014-01826
    Event Type
    Injury
    Date Received
    March 19, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY PRODUCT IDENTIFICATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN; EXPIRATION DATE - UNKNOWN; MANUFACTURE DATE - UNKNOWN.

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS ENROLLED IN A MOM CLINICAL STUDY. 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. PATIENT ALSO REPORTED PAIN, POPPING, LIMPING, AND DECREASED RANGE OF MOTION DURING FOLLOW UP TESTING. 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 (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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162581 M2A 38MM MOD HD -3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 548760

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R