BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9075491 · Received September 17, 2019

    Report

    Report Number
    1818910-2019-104838
    Event Type
    Injury
    Date Received
    September 17, 2019
    Date of Event
    April 1, 2016
    Report Date
    August 29, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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. 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. 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

    LITERATURE ARTICLE RECEIVED ENTITLED "RADIOGRAPHIC TEMPLATING OF TOTAL HIP ARTHROPLASTY FOR FEMORAL NECK FRACTURES". LITERATURE ARTICLE ENTITLED, ¿RADIOGRAPHIC TEMPLATING OF TOTAL HIP ARTHROPLASTY FOR FEMORAL NECK FRACTURES¿ BY DROR LAKSTEIN, ET AL, PUBLISHED BY INTERNATIONAL ORTHOPAEDICS (2017), VOL. 41, PP. 831-836 WAS REVIEWED FOR MDR REPORTABILITY. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE USE OF PRE-OPERATIVE DIGITAL TEMPLATING TO MINIMIZE COMPLICATIONS INCLUDING LIMB LENGTH DISCREPANCY (LLD), INTRAOPERATIVE FRACTURES AND EARLY DISLOCATIONS IN PATIENTS WITH INTRACAPSULAR FEMORAL NECK FRACTURES. THE AUTHORS RETROSPECTIVELY COMPARED 23 PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY (THA) FOR INTRACAPSULAR FEMORAL FRACTURES WITH PRE-OPERATIVE DIGITAL TEMPLATING AND 48 PATIENTS WITHOUT TEMPLATING. BETWEEN JANUARY 2009 AND AUGUST 2012, 193 PATIENTS UNDERWENT HIP ARTHROPLASTY SECONDARY TO A FEMORAL NECK FRACTURE AT OUR INSTITUTION: SEVENTY-FIVE HAD THA AND 118 HAD HEMIARTHROPLASTIES. THE STUDY GROUP INCLUDED THE PATIENT POPULATION TREATED SINCE THE INCEPTION OF ROUTINE TEMPLATING OF THA FOR FRACTURES ON FEBRUARY 2011. PATIENTS WITH PRE-EXISTING AND/OR CONTRALATERAL NATIVE HIP DEFORMITY OR PRIOR HIP SURGERY WERE EXCLUDED. TWENTY-THREE CONSECUTIVE PATIENTS (18 FEMALES) WITH THE MEAN AGE OF 72 (RANGE, 57¿88) WERE INCLUDED. THE CEMENTLESS CORAIL STEMS AND PINNACLE CUPS (DEPUY, WARSAW, INDIANA) WERE UTILIZED. ROUTINE PRE-OPERATIVE PLANNING WAS PERFORMED BY THE SURGEON USING TRAUMACAD (TRAUMACAD, PETACH-TIKVA, ISRAEL). TEMPLATING WAS PERFORMED ON THE CONTRALATERAL SIDE. TEMPLATING BEGAN WITH MARKING A HORIZONTAL REFERENCE LINE TANGENTIAL TO THE INFERIOR POINT OF BILATERAL ISCHIUM. WITHIN THE GROUP OF PATIENTS HAVING RECEIVED TEMPLATING, THE TEMPLATED AND USED FEMORAL COMPONENT MATCHED IN EIGHT OF THE CASES. IN SEVEN PATIENTS THE DIFFERENCE WAS 1 SIZE, WHILE IN FOUR PATIENTS IT WAS 2 SIZES AND IN FOUR OTHER PATIENTS, THE DISCREPANCY WAS 3 SIZES. MEAN POST-OPERATIVE LLD WAS SIGNIFICANTLY LOWER IN PATIENTS WHO HAD PRE-OPERATIVE TEMPLATING THAN IN THE CONTROL GROUP (6.7 MM VS. 11.5 MM, P = 0.023). FIVE PATIENTS (21%) WITH TEMPLATING AND 28 (41 %) PATIENTS WITHOUT TEMPLATING HAD LIMB-LENGTH DISCREPANCY OF 1 CM OR MORE (P = 0.051). ONLY THREE PATIENTS (13 %) WITH TEMPLATING HAD LLD OF MORE THAN 1.5 CM, COMPARED TO 15 PATIENTS (31 %) WITHOUT TEMPLATING (P = 0.17). THERE WAS ONE CASE OF INTRA-OPERATIVE FEMORAL CRACKING AND ONE CASE OF EARLY DISLOCATION IN THE NON-TEMPLATED GROUP. THE DISLOCATED HIP WAS REVISED. THERE WAS ONE CASE OF SUPERFICIAL INFECTION IN EACH GROUP, TREATED SUCCESSFULLY WITH ANTIBIOTICS. SIGNIFICANT IMPROVEMENT IN POST-OPERATIVE LLD WAS ACHIEVED WITH THE INTRODUCTION OF PRE-OPERATIVE TEMPLATING, THOUGH NOT AS SUCCESSFUL AS OTHER CITED STUDIES. THE AUTHORS DO NOT IDENTIFY SPECIFIC PATIENTS WITH HARMS WITHIN THE TEXT OF THE DOCUMENT. THE HEAD AND LINER USED IN THIS STUDY ARE UNIDENTIFIED BUT ASSUMED TO BE DEPUY PRODUCTS DUE TO THE USE OF DEPUY CUP AND STEM IN ALL PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873760 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention