BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9254033 · Received October 29, 2019

    Report

    Report Number
    1818910-2019-112969
    Event Type
    Injury
    Date Received
    October 29, 2019
    Date of Event
    April 28, 2013
    Report Date
    October 7, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. 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, ""RETAINING WELL-FIXED CEMENTLESS STEM IN THE TREATMENT OF INFECTED HIP ARTHROPLASTY"" WRITTEN BY YOUNG-KYUN LEE, KEE HAENG LEE, JAE-HWI NHO, YONG-CHAN HA & KYUNG-HOI KOO PUBLISHED BY ACTA ORTHOPAEDICA 2013; 84 (3): 260¿264 PUBLISHED ONLINE 28 APRIL 2013 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO DETERMINE WHETHER INFECTION AFTER HIP ARTHROPLASTY CAN BE TREATED WITHOUT REMOVAL OF A WELL FIXED STEM. DATA WAS COMPILED FROM 19 PATIENTS IN 3 HOSPITALS (7 MEN AND 12 WOMEN, 19 HIPS RECEIVING A 2 STAGE REVISION TREATMENT FOR INFECTION FROM JANUARY 2005 TO APRIL 2010. IT IS NOTED THAT A TABLE ON PAGE 261 PROVIDES A LIST OF ALL PATIENTS WITH IDENTIFIERS AND IDENTIFIED PRODUCTS. EACH PATIENT WITH DEPUY PRODUCTS IS CAPTURED INDIVIDUALLY ON LINKED COMPLAINTS. ALL PATIENTS HAD ALL IMPLANTS EXPLANTED THEN RECEIVED AN ANTIBIOTIC IMPREGNATED SPACER FOR A VARIED DURATION OF TIME WITH BONE GRAFTING IF NECESSARY AND THEN FINAL STAGE OF NEW IMPLANTS THAT ARE NOT IDENTIFIED. THIS COMPLAINT CAPTURES CASE (B)(6) A MALE (B)(6) WITH INITIAL CORAIL STEM THAT RECEIVED NO IRRIGATION AND DEBRIDEMENT FOR INFECTION 6 MONTHS POST INITIAL IMPLANTATION FOLLOWED BY SPACER IMPLANTATION DURATION OF 4 MONTHS BEFORE RECEIVING NEW UNIDENTIFIED IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047858 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention