BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 11164672 · Received January 13, 2021

    Report

    Report Number
    1818910-2021-00990
    Event Type
    Injury
    Date Received
    January 13, 2021
    Date of Event
    April 30, 2020
    Report Date
    January 5, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. EXAMINATION OF THE PROVIDED X-RAYS IMAGES CONFIRMS THE REPORTED BONE FRACTURE. THE PATIENT HAD ANATOMICAL FEMORAL BONE DEFECTS PRIOR PLACEMENT OF ANY DEPUY DEVICE. THERE IS NO INDICATION THE BONE FRACTURES ARE RELATED TO THE DEFINITIVE FEMORAL STEM. NOTHING INDICATIVE OF A PRODUCT PROBLEM IS IDENTIFIED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : A DEVICE HISTORY RECORD (MRE) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    "LITERATURE ARTICLE ENTITLED ""TOTAL HIP ARTHROPLASTY WITH TROCHANTERIC OSTECTOMY FOR PATIENTS WITH ANGULAR DEFORMITY OF THE PROXIMAL FEMUR"" WRITTEN BY JUNG-TAEK KIM, HONG SEOK KIM, YOUNG-KYUN LEE,YONG-CHAN HA, AND KYUNG-HOI KOO PUBLISHED BY THE JOURNAL OF ARTHROPLASTY PUBLISHED ONLINE/ACCEPTED BY PUBLISHER 30 APR 2020 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO FOLLOW 15 PATIENTS (17 HIPS) UNDERGOING TOTAL HIP ARTHROPLASTY WITH A PROXIMAL FEMORAL DEFORMITY. PROCEDURE-SPECIFIC COMPLICATIONS WERE EVALUATED, SUCH AS INTRAOPERATIVE FEMORAL FRACTURE, STEM MALPOSITION, WEAKNESS OF THE ABDUCTOR POWER, AND LIMP. RADIOLOGICAL CHANGES AND STABILITY OF THE STEMS WERE ASSESSED AT A MEAN OF 7.1 YEARS FOLLOW-UP. X-RAY IMAGES CAN BE FOUND ON PAGE 5, 6, AND 7 OF THE ARTICLE. ADVERSE EVENTS: OF THE 17 HIPS, ONLY TWO STEMS AND TWO CUPS WERE DEPUY. THE REMAINING HIPS WERE COMPETITOR. THERE WERE 4 INDICATED INTRA-OPERATIVE FEMORAL BONE FRACTURES DURING THE PRIMARY OPERATION. THREE OF THE FOUR FRACTURES INVOLVED A COMPETITOR STEM. A STEM WILL BE CAPTURED ON THIS PC FOR FEMORAL BONE FRACTURE. ALL INTRA-OPERATIVE FRACTURES WERE ADDRESSED DURING THE PRIMARY OPERATION. X-RAY INDICATED 6 PATIENTS WERE EXPERIENCING HETEROTROPHIC OSSIFICATION. THERE IS NO INDICATED REVISION NOR INVASIVE TREATMENT TO ADDRESS HETEROTROPHIC OSSIFICATION. A STEM WILL BE CAPTURED ON THIS PC FOR HETEROTROPHIC OSSIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64226 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention