BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 12

    MDR report key: 7826763 · Received August 29, 2018

    Report

    Report Number
    1818910-2018-68034
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    August 7, 2018
    Report Date
    August 7, 2018
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 # ==> PC-(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). 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. DEVICE HISTORY LOT : 5020833 DEVICE HISTORY REVIEW: THE DHR ANALYSIS OF THE BATCH INDICATED SHOWS AN INITIAL CONFORMANCE OF THIS PRODUCT WITH REGARDS TO ITS SPECIFICATION. FOR THIS BATCH, THERE WAS NO DEVIATION OR NON-CONFORMANCE. 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

    REVISION HIP: (B)(6) HOSPITAL (B)(6) 2018. PRIMARY IMPLANT YEAR 2009. STEM, LINER AND HEAD WAS REMOVED DUE TO PATIENT EXPERIENCING PAIN AND SURGEON QUESTIONING THAT THE STEM WAS LOOSE. MALE PATIENT (B)(6). UNKNOWN JRN: CORAIL HO 13 - DISCARDED; UNKNOWN JRN: METAL HEAD 32 +5 - DISCARDED; UNKNOWN JRN: MARATHON LIPPED LINER 58/32 - DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671406 CORAIL2 NON COL HO SIZE 12 HIP FEMORAL STEM JDI DEPUY FRANCE SAS 3003895575 5020833

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention