BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-STEM AMT SZ4 HI OFFSET

    MDR report key: 5534425 · Received March 30, 2016

    Report

    Report Number
    1818910-2016-16387
    Event Type
    Injury
    Date Received
    March 30, 2016
    Date of Event
    November 6, 2015
    Report Date
    February 17, 2016
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4). 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

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT WAS RE-OPENED (PREVIOUSLY (B)(4)) FOLLOWING RECEIPT OF ADDITIONAL INFORMATION. A REVIEW OF THE INFORMATION IDENTIFIED NO ADDITIONAL INVESTIGATIONAL INPUTS. NO FURTHER INVESTIGATION WAS REQUIRED AND NO CHANGES WERE REQUIRED TO THE PREVIOUS INVESTIGATION CONCLUSIONS. 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 UNDERWENT A REVISION DUE TO PAIN.

    Description of Event or Problem · 1

    ASR REVISION, ASR XL, LEFT HIP, REASON(S) FOR REVISION: PAIN. UPDATE: SEE (B)(4) EMAIL DATED 19 FEB. ADDED SCF. (LF (B)(6) 2016.) UPDATE: SEE (B)(4) EMAIL DATED (B)(6) 2016. UPDATED CUP LOT NUMBER AND STEM PRODUCT CODE AND LOT NUMBER. ADDED PATIENT NAME AND DATE OF BIRTH. UPDATED SURGEON NAME. RESUBMIT MEDDEV. (LF (B)(6) 2016). DOI: (B)(6) 2007; DOR: (B)(6) 2015; LEFT HIP. UPDATE JAN 23, 2018: ADDITIONAL INFORMATION RECEIVED FROM CRAWFORD, AS PER REVIEW OF THE NEW INFORMATION THERE IS NO UPDATE TO THE PC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191093 C-STEM AMT SZ4 HI OFFSET HIP FEMORAL STEM/SLEEVE JDI DEPUY INTERNATIONAL LTD - 8010379 1914106

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention