BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 14

    MDR report key: 9117189 · Received September 25, 2019

    Report

    Report Number
    1818910-2019-106109
    Event Type
    Injury
    Date Received
    September 25, 2019
    Date of Event
    September 4, 2019
    Report Date
    September 4, 2019
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWL
    UDI-DI
    10603295258056
    PMA / PMN Number
    K123991
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION DEPUY SYNTHES OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION SINCE RELEASE FOR DISTRIBUTION. 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: NULL. DEVICE HISTORY BATCH:NULL. DEVICE HISTORY REVIEW: NULL. 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). 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 HAD A TOTAL HIP PINNACLE CORAIL DONE 8 WEEKS AGO AT LAHEY HOSPITAL. PATIENT POST OP EXPERIENCED STEM SUBSIDENCE DUE TO WHAT LOOKED LIKE AN UNDERSIZED SIZE 14 KHO STEM. THE PATIENT LEG LENGTHS WERE 17 MM SHORT ON THE RIGHT HIP AND WAS EXPERIENCING THIGH PAIN. UPON STEM REMOVAL THE STEM WAS WELL FIXED AND SIGNIFICANT WORK WAS NEEDED TO LOOSEN IMPLANT TO BONE INTERFACE. WE REMOVED THE 14 KHO CORAIL STEM, 36 +5 BIOLOX HEAD, AND THE 58 PINNACLE +4 10 DEGREE LINER. DR. BARATZ REIMPLANTED A 18 HIGH OFFSET CORAIL REVISION STEM, 36 +1.5 BIOLOX HEAD, AND NEW 58 +4 NEUTRAL LINER. DOI: (B)(6) 2019. DOR: (B)(6) 2019, RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914400 CORAIL2 NON COL HO SIZE 14 HIP FEMORAL STEM KWL DEPUY FRANCE SAS - 3003895575 5326544 10603295258056

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention