BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 8908833 · Received August 19, 2019

    Report

    Report Number
    1818910-2019-101588
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    June 24, 2015
    Report Date
    August 7, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 NUMBER 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. 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

    PRODUCT COMPLAINT # (B)(4). POLYETHYLENE LINER DISSOCIATION IS A COMPLICATION OF THE DEPUY PINNACLE CUP: A REPORT OF 23 CASES" BY ANDREW YUN MD, EMMANUEL N. KOLI MD, JOHN MORELAND MD, RICHARD IORIO MD, JOHN F. TILZEY MD, J. WESLEY MESKO MD, GWO-CHIN LEE MD AND MARK FROIMSON MD PUBLISHED ONLINE 24 JUNE 2015 BY CLINICAL ORTHOPAEDICS AND RELATED RESEARCH; DOI 10.1007/S11999-015-4396-5. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITERATURE ARTICLE ENTITLED "POLYETHYLENE LINER DISSOCIATION IS A COMPLICATION OF THE DEPUY PINNACLE CUP: A REPORT OF 23 CASES" BY ANDREW YUN MD, EMMANUEL N. KOLI MD, JOHN MORELAND MD, RICHARD IORIO MD, JOHN F. TILZEY MD, J. WESLEY MESKO MD, GWO-CHIN LEE MD AND MARK FROIMSON MD PUBLISHED ONLINE 24 JUNE 2015 BY CLINICAL ORTHOPAEDICS AND RELATED RESEARCH DOI 10.1007/S11999-015-4396-5 WAS REVIEWED FOR MDR REPORTABILITY. THE ARTICLE ENTAILS 23 CASES OF DEPUY PINNACLE ACETABULAR COMPONENT WITH A POLYETHYLENE LINER FAILURES. ALL 23 CASES REPORTED A NEW AND SUDDEN ONSET OF DISCOMFORT WITH AUDIBLE, REPRODUCIBLE SQUEAKING. INTRA-OPERATIVE FINDINGS WERE WELL-FIXED ACETABULAR COMPONENTS AND FEMORAL IMPLANTS BUT THE LINER WAS FOUND TO HAVE DISPLACED AND ROTATED AWAY FROM ORIGINAL POSITION LEAVING THE FEMORAL HEAD IN DIRECT CONTACT WITH INNER METAL SHELL OF THE ACETABULAR CUP. GROSS INSPECTION REVEALS FRACTURE OF THE THREE ANTIROTATION LOCKING TABS AT THE PERIPHERY OF THE POLYETHYLENE RIM. IT IS NOTED THAT DOCUMENTED MEASUREMENTS OF CUP IMPLANTATION EXCEED OUTSIDE OF DEPUY'S ACCEPTABLE RANGES FOR CERTAIN CASES. CASE 23 IS A (B)(6) YO FEMALE WHO RECEIVED REVISION 12 MONTHS POST INITIAL IMPLANTATION. CUP ABDUCTION 54 DEGREES AND ANTEVERSION 24 DEGREES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698369 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC. 1818910 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention