BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9282860 · Received November 5, 2019

    Report

    Report Number
    1818910-2019-111003
    Event Type
    Injury
    Date Received
    November 5, 2019
    Date of Event
    June 14, 2017
    Report Date
    October 14, 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 PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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: PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY 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 WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). (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, "HIGH INCIDENCE OF EARLY SUBTROCHANTERIC LATERAL CORTICAL ATROPHY AFTER HIP ARTHROPLASTY USING BONE-CONSERVING SHORT STEM" WRITTEN BY YOON JE CHO, CHAN IL BAE, WAN KEUN YOON, YOUNG SOO CHUN, AND KEE HYUNG RHYU PUBLISHED BY INTERNATIONAL ORTHOPAEDICS (SICOT) DOI 10.1007/S00264-017-3544-9 ACCEPTED BY PUBLISHER 14 JUNE 2017 WAS REVIEWED. THE ARTICLE'S PURPOSE: " IN THIS STUDY, WE INVESTIGATED THE DEGREE TO WHICH THE LATERAL CORTEX WAS RESORBED AND HOW FREQUENTLY THIS PROCESS WAS OBSERVED. MOREOVER, WE TRIED TO IDENTIFY POSSIBLE RISK FACTORS FOR THIS PHENOMENON AMONG VARIOUS AVAILABLE CLINICAL PARAMETERS." DATA WAS COMPILED FROM 80 THAS WITH 31 MALES AND 49 FEMALES AND A MEAN AGE OF 48.2 YEARS. THE MEAN FOLLOW UP PERIOD WAS 37.3 MONTHS (24-51 MONTHS). DEPUY PRODUCTS WERE UTILIZED AMONGST NON DEPUY PRODUCTS: TRILOCK STEM (ALL PATIENTS), PINNACLE CUP (75 CASES), COC BEARING. THE ARTICLE REPORTS UPON GENERALIZED ADVERSE EVENTS AND ALSO CAPTURES 2 PATIENTS WITH IDENTIFIERS THAT ARE CAPTURED INDIVIDUALLY ON LINKED COMPLAINTS. THIS COMPLAINT CAPTURES THE GENERALIZED ADVERSE EVENTS: OSTEOLYTIC LESION ON FEMUR ALONG WITH REDUCTION IN LATERAL CORTICAL THICKNESS (BONE INJURY), NON-DISPLACE INTRAOPERATIVE FRACTURE TREATED WITH CIRCLAGE WIRING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071407 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention