BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML HIGH OFFSET LG STAT 13.5MM

    MDR report key: 2833569 · Received November 15, 2012

    Report

    Report Number
    1818910-2012-26460
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    August 15, 2012
    Report Date
    February 6, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K012364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    **UPDATE** 10/25/2012- LITIGATION PAPERS RECEIVED. IN ADDITION TO PREVIOUSLY REPORTED ALLEGATIONS, IT IS NOW ALLEGED THAT THE PATIENT SUFFERS FROM METALLOSIS AND LOOSENING. AN UNKNOWN DEVICE HAS BEEN ADDED TO ENSURE COVERAGE FOR ALLEGED LOOSENING. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE CORRECTIVE ACTION WAS NOT ESTABLISHED. 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

    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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS AN ADVERSE TISSUE REACTION, WITH PAIN AND SWELLING NEAR HIP. **UPDATE** (B)(4) 2012- LITIGATION PAPERS RECEIVED. IN ADDITION TO PREVIOUSLY REPORTED ALLEGATIONS, IT IS NOW ALLEGED THAT THE PATIENT SUFFERS FROM METALLOSIS AND LOOSENING. AN UNKNOWN DEVICE HAS BEEN ADDED TO ENSURE COVERAGE FOR ALLEGED LOOSENING.

    Description of Event or Problem · 1

    UPDATE (B)(6) 2017 - (TRANSFER WPC 12316-2012) PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISING SURGEON IN HIS SURGICAL INDICATIONS REPORTED THAT A PRE-OP ASPIRATION OF PATIENT'S RIGHT HIP ONE WEEK PRIOR "RETURNED MOTOR OIL-LIKE FLUID FROM THE RIGHT HIP". OPERATIVE NOTE INDICATED "EVIDENCE OF BROWNISH CAPSULAR TISSUE INDICATIVE OF EARLY ADVERSE LOCAL TISSUE REACTION". ALSO, "THERE WAS A SMALL AMOUNT OF EVIDENCE OF CORROSION FROM THE HEAD-TRUNNION INTERFACE". THERE WERE NO IDENTIFIED LOOSE COMPONENTS. POST-OP DIAGNOSIS "ADVERSE LOCAL TISSUE REACTION, RIGHT HIP". PATHOLOGY REPORT OF REVISION HIP CAPSULE TISSUE STATES "PATCHY DENSE PERIVASCULAR LYMPHOCYTE INFLAMMATION IS PRESENT CONSISTENT WITH THE HISTORY OF METAL-ON-METAL REACTION". METAL ION LABS REPORTED < 7.0 PPB. THE UNKNOWN DEVICE WILL BE ASSIGNED AS STEM AND CODED FOR CORROSION HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AML HIGH OFFSET LG STAT 13.5MM HIP FEMORAL STEM/SLEEVE JDI DEPUY ORTHOPAEDICS INC US B3LFW1000

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention