BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR LINERS

    MDR report key: 9249453 · Received October 29, 2019

    Report

    Report Number
    1818910-2019-110312
    Event Type
    Injury
    Date Received
    October 29, 2019
    Date of Event
    December 26, 2016
    Report Date
    October 7, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). PATIENT CODE: OSSIFICATION.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: CORRECTED: H6. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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 : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE ENTITLED, "CONVERSION HIP ARTHROPLASTY IN FAILED FIXATION OF INTERTROCHANTERIC FRACTURE: A PROPENSITY SCORE MATCHING STUDY" WRITTEN BY YOUNG-KYUN LEE, MD, JUNG TAEK KIM, MD, AWAD ABDALLA ALKITAINI, MD, KI-CHOUL KIM, MD, YONG-CHAN HA, MD, AND KYUNG-HOI KOO, MD PUBLISHED BY THE JOURNAL OF ARTHROPLASTY 32 (2017) 1593-1598 PUBLISHED ONLINE 22 DECEMBER 2016 WAS REVIEWED. THE ARTICLE'S PURPOSE: "TO DETERMINE WHETHER THERE WERE DIFFERENCES IN THE TYPE OF ARTHROPLASTY, OPERATIVE PARAMETERS, PERIOPERATIVE MORBIDITY, 1-YEAR MORTALITY, AND POSTOPERATIVE OUTCOME BETWEEN CONVERSION HIP ARTHROPLASTY DUE TO FIXATION FAILURE AND PRIMARY HIP ARTHROPLASTY IN INTERTROCHANTERIC FRACTURE. " DATA WAS COMPILED FROM 33 PATIENTS (33 HIPS WITH MEAN AGE OF 74.1 YEARS AND MEAN INTERVAL BETWEEN INTERNAL FIXATION AND CONVERSION THA OF 11 MONTHS WITH PROCEDURES PERFORMED OCTOBER 2003 AND MARCH 2015 FOR EACH GROUP (CONVERSION GROUP AND CONTROL GROUP). DEPUY PRODUCTS UTILIZED IN CONVERSION GROUP: KAR STEM (6), CORAIL STEM(1), PINNACLE CUP (1). ALL OTHER COMPONENTS WERE NON-DEPUY IN THIS GROUP. DEPUY PRODUCTS UTILIZED IN CONTROL GROUP: KAR STEM (10), CORAIL STEM (3), PINNACLE CUP (3). ALL OTHER COMPONENTS WERE NON-DEPUY IN THIS GROUP. ADVERSE EVENTS: BLOOD TRANSFUSION (RANGE BETWEEN 500-1800 ML TOTAL), STEM MALPOSITION, POSTOPERATIVE PERIPROSTHETIC FRACTURE OF FEMUR TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION, HETEROTOPIC OSSIFICATION. THE ARTICLE DOES NOT IDENTIFY PRODUCTS ASSOCIATED WITH THE ADVERSE EVENTS. TABLE 2 DEMONSTRATE ALMOST ALL ADVERSE EVENTS ASSOCIATED WITH THE CONVERSION GROUP WITH THE EXCEPTION BLOOD TRANSFUSIONS WHICH WAS REQUIRED IN BOTH GROUPS. THE ARTICLE DOES NOT PROVIDE ADEQUATE INFORMATION TO DIRECTLY ASSOCIATE DEPUY PRODUCTS WITH SPECIFIC ADVERSE EVENTS AND ONLY PROVIDES INFORMATION THAT DEPUY PRODUCTS WERE IN EACH GROUP AMONG THE MAJORITY OF NON-DEPUY PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045544 UNKNOWN HIP ACETABULAR LINERS HIP ACETABULAR LINERS KWY DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention