BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 43

    MDR report key: 8055062 · Received November 9, 2018

    Report

    Report Number
    1818910-2018-75123
    Event Type
    Injury
    Date Received
    November 9, 2018
    Date of Event
    October 12, 2015
    Report Date
    October 18, 2018
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NVESTIGATION 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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). PATIENT CODE: NO CODE AVAILABLE ((B)(4)) USED TO CAPTURE THE SURGICAL INTERVENTION. . IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. Z-1749/1816-2011.

    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, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: 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. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER MDD CAPA-(B)(4). ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT. 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

    UPDATE (B)(4) 2018. ORIGINAL IMPLANTATION DATE - (B)(4)2006. DATE OF REVISION - (B)(4)/2015. REASON FOR REVISION - ACUTE ONSET & CONTINUING PAIN IN THE HIP WITHOUT INJURY. NO RADIOLOGICAL ADVERSE FEATURES NOTED. AT SURGERY, FEMORAL PEG SEEN TO BE DETACHED (BROKEN) FROM THE DOME. SIDE - LEFT LOT NO - 2002457 (ACETABULUM), 1820416 (FEMUR) . ANY DELAY - 4 MONTHS FROM ONSET OF SYMPTOM TO SURGERY. GIVEN THE COMPLEXITY OF THE DIAGNOSIS, THIS WAS A REASONABLE TIME TO WAIT. THE PRODUCT NUMBERS ARE: REF (B)(4) LOT 2002457 REF (B)(4)LOT 1820416.

    Description of Event or Problem · 1

    ASR THAT WAS REVISED AND UPON REVISION IT WAS NOTED THAT THE ¿PEG¿ HAD SEPARATED FROM THE ASR DOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894391 TOTAL ASR FEM IMP SIZE 43 HIP FEMORAL HEAD JDI DEPUY INTERNATIONAL LTD - 8010379 1820416

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention