BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 22F-XXL

    MDR report key: 3770346 · Received April 24, 2014

    Report

    Report Number
    1818910-2014-17432
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    July 24, 2009
    Report Date
    July 3, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. 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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS OTHER REPORTS AGAINST THE ACETABULAR CUP. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. OTHER REPORTS WERE IDENTIFIED IN THE SEARCH AGAINST THE FEMORAL HEAD AND/OR METAL INSERT. PER PROCEDURE, THESE DEVICES ARE EXEMPT FROM DEVICE HISTORY RECORD REVIEW. NO OTHER REPORTS WERE IDENTIFIED IN THE SEARCH AGAINST THE REMAINING PRODUCT/LOT CODE COMBINATIONS. X-RAYS WERE RECEIVED AND REVIEWED WITH NOTHING INDICATIVE OF A DEVICE NONCONFORMANCE FOUND. THE PATIENT WAS INITIALLY IMPLANTED WITH DEPUY DEVICE IN (B)(6) 2005 AND REVISED FOR INFECTION IN (B)(6) 2009. IT IS NOT LIKELY OR REASONABLE TO CONCLUDE THE DEPUY DEVICES CONTRIBUTED TO THE PATIENT'S REPORTED INFECTION MORE THAN FOUR YEARS POST PRIMARY IMPLANTATION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN 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.

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

    Description of Event or Problem · 1

    UPDATE REC'D 7/3/2014-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE REVISION OPERATIVE NOTE CONFIRMED INFECTION AND OSTEOLYSIS. WHILE REMOVING THE SLEEVE A NONDISPLACED CRACK ON THE GREATER TROCHANTER WAS NOTICED. THERE WAS NO MENTION OF METALLOSIS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    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 ¿ THE PATIENT WAS REVISED BECAUSE OF INFECTION. UPDATE 4/8/2011 - MEDICAL RECORDS WERE RECEIVED. THE POSTOPERATIVE DIAGNOSIS STATES: PROBLEMATIC LEFT TOTAL HIP REPLACEMENT WITH METAL-ON-METAL BEARING COMPONENT-INDUCED OSTEOLYSIS AND LATE INSTABILITY OF THE TOTAL HIP REPLACEMENT. THE COMPLAINT WAS REOPENED TO UPDATE THE MDR DECISION. UPDATE REC¿D (3/27/2014) - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, METALLOSIS AND FLUID BUILD-UP. WE ARE REPORTING ALL PRODUCTS DUE TO INFECTION BEING ALLEGED. THE COMPLAINT WAS UPDATED ON : 4/24/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249675 S-ROM*SLEEVE PRX ZTT, 22F-XXL HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS INC US 1165730

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention