BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOL 2.25X15.0 CALCAR 9.0 R

    MDR report key: 3180552 · Received June 20, 2013

    Report

    Report Number
    1818910-2013-19412
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    January 16, 2012
    Report Date
    May 24, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK953703
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE STERILIZATION CERTIFICATIONS FOR THE PROVIDED PRODUCT/LOT COMBINATIONS DID NOT REVEAL ANY RELATED DEVIATIONS OR ANOMALIES. PER THE STERILIZATION CERTIFICATES, VALIDATED PARAMETERS WERE MET. NO ERROR IN STERILE PROCESSING WAS IDENTIFIED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. INFECTION AFTER THIS LENGTH OF TIME IMPLANTED IS NOT LIKELY TO INVOLVE A DEVICE / DEVICE PROCESSING ERROR. 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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT.- PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2007 - DOR: (B)(6) 2012 (RIGHT HIP). UPDATE (B)(4) 2013 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE A POST OP XRAY ON (B)(6) 2011 REVEALED SUBSIDENCE AND PROBABLE STEM LOOSENING. THE MANUFACTURER OF THE CEMENT USED AT THE TIME OF IMPLANTATION IS UNKNOWN. THE FEMORAL STEM IS BEING REPORTED AT THIS TIME, AND A AN ACETABULAR SCREW IS BEING ADDED TO THE COMPLAINT AS RECORDS INDICATED THE PATIENT HAD A SCREW FOR CUP FIXATION THAT WOULD HAVE BEEN REMOVED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281216 SOL 2.25X15.0 CALCAR 9.0 R STEM LPH 1818910 DEPUY ORTHOPAEDICS, INC. Z23K11000

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention