BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 10547580 · Received September 17, 2020

    Report

    Report Number
    1818910-2020-20363
    Event Type
    Injury
    Date Received
    September 17, 2020
    Report Date
    July 9, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. ALL AVAILABLE X-RAYS WERE REVIEWED. THE REPORTED LOOSE CONDITION CANNOT BE CONFIRMED. BASED ON THE PROVIDED EVIDENCE, IT CANNOT BE DETERMINE A PROGRESSIVE DECAY OF IMPLANT POSITION IN RELATION TO INITIAL IMPLANTATION POSITION. 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. DEVICE HISTORY LOT : A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED FOR THIS DEVICE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. (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

    PINNACLE LITIGATION RECORD RECEIVED. PLAINTIFF ALLEGES PAIN, MUSCLE WEAKNESS AND WALKING DIFFICULTY. PFS ALLEGES LOOSE CUP, FRACTURE COMPONENT, DISLOCATION, METAL WEAR AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS, THERE WAS NO REVISION EVENT FOR THE LEFT HIP. DOI: (B)(6) 2013 - DOR: NOT REPORTED (LEFT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012886 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention UNKNOWN HIP ACETABULAR LINERS.| UNKNOWN HIP FEMORAL HEAD.| UNKNOWN HIP FEMORAL STEM.| UNKNOWN HIP ACETABULAR LINERS| UNKNOWN HIP FEMORAL HEAD| UNKNOWN HIP FEMORAL STEM