BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR LINERS

    MDR report key: 9200315 · Received October 16, 2019

    Report

    Report Number
    1818910-2019-108692
    Event Type
    Injury
    Date Received
    October 16, 2019
    Date of Event
    August 15, 2015
    Report Date
    September 26, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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, "EXTRACTION OF WELL-FIXED EXTENDED POROUS-COATED CEMENTLESS STEMS USING A FEMORAL LONGITUDINAL SPLIT PROCEDURE" WRITTEN BY SATOSHI NAGOYA, MIKITO SASAKI, MITSUNORI KAYA, SHUNICHIRO OKAZAKI, KENJI TATEDA AND TOSHIHIKO YAMASHITA PUBLISHED BY EUR ORTHOP TRAUMATOL (2015) 6:417¿421 DOI 10.1007/S12570-015-0322-2 29 ONLINE ON 29 AUGUST 2015 WAS REVIEWED FOR MDR REPORTABILITY. THE ARTICLE'S PURPOSE IS TO INTRODUCE A USEFUL EXTRACTION PROCEDURE FOR WELL-FIXED FEMORAL STEMS AND REPOR THE CLINICAL RESULTS. THE DATE INCLUDES 12 PATIENTS IN WHICH 11 ARE NOTED TO HAVE IMPLANTED DEPUY PRODUCTS. EACH PATIENT IS CAPTURED IN LINKED COMPLAINTS. THIS COMPLAINT CAPTURES CASE 9 OF A (B)(6) FEMALE WITH A L AML PLUS STEM WITH AN INGROWN FIXATION AND A DURALOC CUP WITH CONVENTIONAL POLY ENDURON LINER AND A COCR FEMORAL HEAD WHO REQUIRED ALL IMPLANTS TO BE EXPLANTED DUE TO LATE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992875 UNKNOWN HIP ACETABULAR LINERS HIP ACETABULAR LINERS KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention