BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3005180920-2019-00196

    MDR report key: 8455410 · Received March 27, 2019

    Report

    Report Number
    3005180920-2019-00196
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    February 25, 2019
    Report Date
    March 27, 2019
    PMA / PMN Number
    K161635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON MARCH 27, 2019: ANTERIOR APPROACH WAS USED DURING PRIMARY SURGERY. LATERAL APPROACH WAS USED DURING REVISION SURGERY. BATCH REVIEW PERFORMED ON 25 MARCH 2019: LOT 182810: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUL-2018. EXPIRATION DATE: 2023-06-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: POSTOPERATIVE FEMORAL FRACTURE, FEW DAYS AFTER PRIMARY CEMENTLESS THA. THE FRACTURE PROBABLY HAPPENED DURING WALKING RE-EDUCATION PERIOD OF TIME WHEN A SUDDEN MOVEMENT ON A WEAKENED BONE DUE TO INTRAOPERATIVE FEMORAL PREPARATION MAY FACILITATE THE OCCURRENCE OF THIS EVENT. NO REASON TO SUSPECT THAT THIS EVENT IS DUE TO A FAULTY DEVICE.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO FEMUR BONE FRACTURE OCCURRED 12 DAYS AFTER THE SURGERY. NO FRACTURE WAS DISCOVERED DURING SURGERY. HEAD AND STEM WERE REVISED, THE REVISION WAS PERFORMED WITH QUADRA-R AND BIOLOX HEAD.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention