BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9249511 · Received October 29, 2019

    Report

    Report Number
    1818910-2019-112765
    Event Type
    Injury
    Date Received
    October 29, 2019
    Date of Event
    November 16, 2015
    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 · 1

    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 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, "CEMENTLESS REVISION TOTAL HIP ARTHROPLASTY WITH CERAMIC ARTICULATION" WRITTEN BY JONG-HYUCK YANG, MD, SEONG-JO YANG, MD, JOON-SOON KANG, MD, KYOUNG-HO MOON, MD PUBLISHED BY HIP AND PELVIS 27(4): 223-231, 2015 WITH FINAL PUBLISHER ACCEPTANCE NOVEMBER 16, 2015 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO EVALUATE THE CLINICAL AND RADIOLOGICAL OUTCOMES OF REVISION THA USING THE THIRD AND FOURTH GENERATION COC ARTICULATIONS IN YOUNGER PATIENTS FOR INTERMEDIATE-TERM DURATIONS. DATA WAS COMPILED FROM 103 PATIENTS WHO RECEIVED REVISION THAS BETWEEN JANUARY 2000 TO APRILS 2012 WITH MEAN AGE OF 51.6 YEARS. DEPUY PRODUCTS UTILIZED (ALL PATIENTS): DURALOC CUPS UNTIL JUNE OF 2007 AND THE PINNACLE CUPS WITH CERAMIC LINERS. CERAMIC FEMORAL HEAD WITH AML STEMS AND SOLUTION STEMS. ORIGINAL IMPLANTS ARE NOT KNOWN OR IDENTIFIED. ADVERSE EVENTS: SQUEAKING NOISE (NO INTERVENTIONS OR REVISION), LIMP IN WALKING AND REQUIRE WALKING AIDS, LIMB LENGTH DISCREPANCY (0 TO 2 CM) WITHOUT IMPACT TO FUNCTION AND NO INTERVENTIONS, DISLOCATION TREATED BY CLOSED REDUCTION UNDER GENERAL ANESTHESIA AND ONE TREATED WITH RE-REVISION DUE TO RECURRENT DISLOCATIONS WITH CHANGE OF CUP (NOT IDENTIFIED) AND HEAD, JOINT INFECTIONS TREATED WITH RE-REVISION (PINNACLE CUP IDENTIFIED) WITH CHANGING OF CUP AND FEMORAL HEAD, CUP RE-REVISION DUE TO LOOSENING (PINNACLE CUP IDENTIFIED). THE ARTICLE DOES NOT PROVIDE ADEQUATE INFORMATION TO DETERMINE ACCURATE QUANTITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043767 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention