BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SLEEVE

    MDR report key: 2971914 · Received February 21, 2013

    Report

    Report Number
    1818910-2013-02259
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    September 21, 2012
    Report Date
    January 14, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS AND X-RAYS WERE PROVIDED AND REVIEWED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UPDATE REC'D (B)(4) 2014 - PFS RECEIVED. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED

    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 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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT.- CLINICAL REPORT STATES THE PATIENT WAS REVISED FOR ASEPTIC LOOSENING OF THE STEM DOI: (B)(6) 2007 DOR: (B)(6) 2012 (RIGHT HIP). UPDATE 1/24/2013 - PATIENT'S MEDICAL RECORDS AND X-RAYS RECEIVED. RECORDS INDICATE UPON REVISION METALLIC DEBRIS WAS FOUND AND ALSO LOOSENING OF THE FEMORAL SLEEVE. THE LINER, HEAD, AND SLEEVE WERE ADDED TO THE COMPLAINT. UPDATE: LITIGATION PAPERS RECEIVED 11/13/13. LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. THERE IS NO ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THIS INVESTIGATION. THE COMPLAINT HAS BEEN UPDATED ON 11/25/13 UPDATE REC'D 1/14/2014- PFS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 1/28/13 UPDATE REC'D 1/14/2014- PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE OPERATIVE NOTES THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 2/10/2014 DOI: 01/03/2007 DOR:09/21/2012 (RIGHT HIP) NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UPDATE: LITIGATION PAPERS RECEIVED (B)(4) 2013. LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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

    PRODUCT COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    CLINICAL REPORT STATES, THE PATIENT WAS REVISED FOR ASEPTIC LOOSENING OF THE STEM 1/24/2013 - PATIENT'S MEDICAL RECORDS RECEIVED. RECORDS INDICATE UPON REVISION METALLIC DEBRIS WAS FOUND AND ALSO LOOSENING OF THE FEMORAL SLEEVE.

    Description of Event or Problem · 1

    PPF ALLEGES PSEUDOTUMOR AND METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76375 UNKNOWN DEPUY SLEEVE SLEEVE JWH DEPUY ORTHOPAEDICS INC US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention