BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 4929834 · Received July 21, 2015

    Report

    Report Number
    0001825034-2015-03158
    Event Type
    Injury
    Date Received
    July 21, 2015
    Report Date
    June 12, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE JOURNAL ARTICLE. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY JENSEN C, ET AL. GAIT POSTURE (2015). IT IS LIKELY THAT THESE COMPLICATIONS AND REVISIONS HAVE ALREADY BEEN REPORTED; HOWEVER, IT CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION MADE AVAILABLE IN THE ARTICLE. SHOULD ADDITIONAL INFORMATION RELATING TO THE EVENTS BE RECEIVED, THE UPDATED INFORMATION WILL BE FORWARDED TO THE FDA. PLEASE NOTE: BIOMET ATTEMPTED TO SUBMIT A REPORT TO MAKE FDA AWARE OF THE EVENTS OUTLINED IN THE JOURNAL ARTICLE.. MULTIPLE SUBMISSION ATTEMPTS FAILED ON THE FOLLOWING DATES: (B)(4) 2015. THIS ARTICLE WAS ATTEMPTED FOR SUBMISSION WITHIN THE 30 DAY TIMEFRAME; HOWEVER A NEW REPORT HAD TO BE CREATED (THIS MANUFACTURER REPORT NUMBER) FOR RESUBMISSION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED "THE USE OF THE GAIT DEVIATION INDEX FOR THE EVALUATION OF PARTICIPANTS FOLLOWING TOTAL HIP ARTHROPLASTY: AN EXPLORATIVE RANDOMIZED TRIAL." THE STUDY AIMED TO EVALUATE PRE-TO-POSTOPERATIVE GAIT PATTERN CHANGES AFTER TOTAL HIP ARTHROPLASTY AND IDENTIFY FACTORS WHICH MIGHT BE PREDICTIVE OF OUTCOME. THE GAIT DEVIATION INDEX (GDI) WAS UTILIZED TO MEASURE OUTCOMES AMONG 38 TRIAL PARTICIPANTS. THE OUTCOMES FOR THE PATIENTS WERE AS FOLLOWS: EIGHTEEN (18) PATIENTS IMPROVED. TWELVE (12) PATIENTS SHOWED NO EVIDENCE OF CHANGE. EIGHT (8) PATIENTS DETERIORATED. IN CONCLUSION, DESPITE IMPROVEMENTS, THE RHA PATIENTS DID NOT DEMONSTRATE SIGNIFICANT GREATER IMPROVEMENT IN GDI COMPARED TO THA PATIENTS AT 6 MONTHS AFTER SURGERY. THE PREOPERATIVE GDI SCORE WAS A STRONG PREDICTOR FOR POSTOPERATIVE GAIT QUALITY IMPROVEMENTS, WHILE THERE WAS NO PREDICTIVE VALUE EVIDENT FOR GENDER, AGE AND PREOPERATIVE WALKING SPEED. THE GDI INCREASED AFTER SURGERY, WHICH INDICATES AN OVERALL IMPROVEMENT IN GAIT FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471696 UNKNOWN HIP PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R