BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-LOCK BPS SZ 11 HI OFFSET

    MDR report key: 2901934 · Received January 8, 2013

    Report

    Report Number
    1818910-2013-00796
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    May 31, 2012
    Report Date
    December 14, 2012
    Manufacturer
    DEPUY ORTHOPAEDIC INC, 1818910
    Product Code
    KWA
    PMA / PMN Number
    PK073570
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE 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

    (B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # :(B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. 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

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DIFFICULTY WALKING AND AMBULATING. IT IS ALSO ALLEGED THAT THE PATIENT SUFFERS FROM METALLOSIS. UPDATE: (B)(4) 2012, PLAINTIFF FACT SHEET RECEIVED WITH PART/LOT INFORMATION. MEDICAL RECORDS ALSO INDICATED THAT THE STEM WAS LOOSE.

    Description of Event or Problem · 1

    UPDATE 5/17/16-PFS AND MEDICAL RECORDS RECEIVED. PFS AND MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PFS REPORTED PAIN, DIFFICULTY WALKING OR DOING PHYSICAL ACTIVITIES, LIMITED MOBILITY, LEFT KNEE PAIN AND WALKS WITH LIMP. PRIMARY SURGICAL REPORT NOTED 900ML OF ESTIMATED BLOOD LOSS WITHOUT EXPLANATION OF ANY OCCURRENCE AND NO NOTE OF ANY DEPUY COMPONENTS BEING INVOLVED. REVISION SURGICAL NOTE REPORTED PAIN, DIFFICULTY WITH ACTIVITIES OF DAILY LIVING, NO METALLOSIS AND A BONY PEDESTAL OF FEMUR AT THE FEMORAL STEM. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION. THE COMPLAINT WAS UPDATED ON: JUN 9, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8627 TRI-LOCK BPS SZ 11 HI OFFSET DEPUY STEM KWA DEPUY ORTHOPAEDIC INC, 1818910 DV6GS1

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention