BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEPUY CONSTRAINED LINER

    MDR report key: 3375340 · Received September 30, 2013

    Report

    Report Number
    1818910-2013-28773
    Event Type
    Malfunction
    Date Received
    September 30, 2013
    Date of Event
    August 20, 2013
    Report Date
    September 4, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. PATIENT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED (B)(6) 2013. REVISION OPERATIVE REPORT INDICATES PATIENT WAS REVISED DUE TO SNAPPING AND POPPING FROM THE RIGHT HIP; DISLOCATED HIP; PLASTIC HAD FRACTURED AT THE ANTERIOR SURFACE OF THE LIP; RING NOT FRACTURED BUT WORN; NECK OF THE FEMORAL COMPONENT SHOWED A WEAR PATTERN ON THE ANTERIOR SURFACE; RECURRENT IMPINGEMENT ON THE ANTERIOR ASPECT OF THE CUP WITH HIGH FLEXION MOVEMENT; CUP WAS SLIGHTLY SUBLUXED BENEATH THE ANTERIOR RIM OF THE ACETABULUM. DOI: UNKNOWN - DOR: (B)(6) 2013 (RIGHT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES PATIENT WAS REVISED DUE TO SNAPPING AND POPPING FROM THE RIGHT HIP; DISLOCATED HIP; PLASTIC HAD FRACTURED AT THE ANTERIOR SURFACE OF THE LIP; RING NOT FRACTURED BUT WORN; NECK OF THE FEMORAL COMPONENT SHOWED A WEAR PATTERN ON THE ANTERIOR SURFACE; RECURRENT IMPINGEMENT ON THE ANTERIOR ASPECT OF THE CUP WITH HIGH FLEXION MOVEMENT; CUP WAS SLIGHTLY SUBLUXED BENEATH THE ANTERIOR RIM OF THE ACETABULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491987 UNKNOWN DEPUY CONSTRAINED LINER POLYETHYLENE LINER KWA 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR