BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR LINERS

    MDR report key: 8226150 · Received January 8, 2019

    Report

    Report Number
    1818910-2019-80134
    Event Type
    Injury
    Date Received
    January 8, 2019
    Report Date
    December 10, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 181891
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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). INVESTIGATION SUMMARY: 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 CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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 WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PATIENT COMMUNICATION RECEIVED. AS REPORTED, THE PATIENT HAD A PINNACLE HIP IMPLANTED INTO HIS RIGHT HIP. HIP NEEDS TO BE REVISED DUE TO THE FACT IT KEEPS DISLOCATING. EXACT PRODUCT CODES WERE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22252 UNKNOWN HIP ACETABULAR LINERS HIP ACETABULAR LINERS KWA DEPUY ORTHOPAEDICS, INC. 181891

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention