BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ6 STD OFF

    MDR report key: 2162258 · Received July 7, 2011

    Report

    Report Number
    1818910-2011-12658
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    January 6, 2011
    Report Date
    June 7, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THEY REPORT STATES: PATIENT WAS REVISED TO ADDRESS PERSISTANT EFFUSION AND POSSIBLE INFECTION. DOI: UNK; DOR: (B)(6) 2011 (RIGHT SIDE). **UPDATE** (B)(6) 2011- RECEIVED LITIGATION PAPERS. THEY ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON HIS RIGHT SIDE ON OR ABOUT (B)(6) 2008. FOLLOWING THE SURGERY, PATIENT EXPERIENCED PAIN, DISCOMFORT, AND SORENESS, WHICH IN TURN NEGATIVELY AFFECTED PATIENTS ABILITY TO WALK, MOVE AND SLEEP AND UNDERWENT REVISION SURGERY FOR ASEPTIC FAILURE OF HIS ASR COMPONENT. SUBSEQUENTLY, HE EXPERIENCED PAIN, DISCOMFORT, SWELLING, AND DRAINAGE FROM A SEROMA AND UNDERWENT PLACEMENT OF A DRAIN ON OR ABOUT (B)(6) 2010 AND EVENTUAL IRRIGATION AND DEBRIDEMENT WITH MODULAR COMPONENT EXCHANGE WITH BURSECTOMY AND SYNOVECTOMY ON OR ABOUT (B)(6) 2011. FOLLOWING SUBSEQUENT EVIDENCE OF INFECTION, HE UNDERWENT A TWO STAGE REVISION ON OR ABOUT (B)(6) 2011 AND (B)(6) 2011 WITH INTERVENING ANTIBIOTIC REGIMEN WHICH INCLUDED PLACEMENT OF A PICC LINE FOR INTRAVENOUS ANTIBIOTICS. HE CONTINUES TO EXPERIENCE PAIN AND DISCOMFORT. PATIENT HAD HIS IMPLANT REMOVED ON (B)(6) 2010. EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATION WAS NOT PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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 THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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

    PATIENT FACT SHEET (PFS) FORM RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    UPDATE REC'D 3/28/2013 - PPD AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE REVISION OPERATIVE NOTE INDICATED A MALPOSITIONED CUP. IT ALSO NOTED THERE WAS NO INFECTION. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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 WAS REVISED TO ADDRESS PERSISTENT EFFUSION AND POSSIBLE INFECTION. UPDATE: (B)(6) 2011 - RECEIVED LITIGATION PAPERS. THEY ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON HIS RIGHT SIDE ON OR ABOUT (B)(6) 2008. FOLLOWING SURGERY, PATIENT EXPERIENCED PAIN, DISCOMFORT, AND SORENESS, WHICH IN TURN NEGATIVELY AFFECTED PATIENT'S ABILITY TO WALK, MOVE AND SLEEP AND UNDERWENT REVISION SURGERY FOR ASEPTIC FAILURE OF HIS ASR COMPONENT. SUBSEQUENTLY, HE EXPERIENCED PAIN, DISCOMFORT, SWELLING, AND DRAINAGE FROM A SEROMA AND UNDERWENT PLACEMENT OF A DRAIN ON OR ABOUT (B)(6) 2010 AND EVENTUAL IRRIGATION AND DEBRIDEMENT WITH MODULAR COMPONENT EXCHANGE WITH BURSECTOMY AND SYNOVECTOMY ON OR ABOUT (B)(6) 2011. FOLLOWING SUBSEQUENT EVIDENCE OF INFECTION, HE UNDERWENT A TWO STAGE REVISION ON OR ABOUT (B)(6) 2011 AND (B)(6) 2011 WITH INTERVENING ANTIBIOTIC REGIMEN WHICH INCLUDED PLACEMENT OF A PICC LINE FOR INTRAVENOUS ANTIBIOTICS. HE CONTINUES TO EXPERIENCE PAIN AND DISCOMFORT. PATIENT HAD HIS IMPLANT REMOVED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT POR TAPER SZ6 STD OFF FEMORAL STEM LPH DEPUY ORTHOPAEDICS, INC. NA CC4EW1000

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention