BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 LAT COXA VARA SIZE 13

    MDR report key: 7726453 · Received July 27, 2018

    Report

    Report Number
    1818910-2018-65349
    Event Type
    Injury
    Date Received
    July 27, 2018
    Date of Event
    April 3, 2018
    Report Date
    July 3, 2018
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    LZO
    UDI-DI
    10603295168904
    PMA / PMN Number
    K192946
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS 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. 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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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: ADDED:H6(DEVICE CODES) 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. 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 WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: ADDED: A4, A5, A6, B5, B6, B7, D10, E1, E2, E3, E4, G4, H6 (CLINICAL, IMPACT AND MEDICAL DEVICE PROBLEM CODES). E3 INITIAL REPORTER OCCUPATION: LAWYER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    PFS ALLEGES PAIN, DISCOMFORT, WEAKNESS IN HIPS AND LEGS, DIFFICULT ADL, DISLOCATION, METAL IONS EXPOSURE AND EMOTIONAL DISTRESS. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED IN THE MEDICAL RECORDS CLINICAL VISIT REPORTED ON (B)(6), 2018 PRESENT ILLNESS WERE DIAPHORESIS, PALPITATIONS, COLD INTOLERANCE AND DIZZINESS, MEMORY LOSS, WALKS WITH SLIGHT ANTALGIA. LAB RESULT FOR METAL IONS WERE ABOVE 7 PPB. DOI: (B)(6), 2006, DOR: (B)(6), 2018, RIGHT HIP. EVENT DATE: (B)(6) 2018: PATIENT PRESENTED AT ER WITH PAIN, STIFFNESS, AND INSTABILITY SECONDARY TO A RIGHT HIP DISLOCATION AFTER BENDING OVER AND FEELING A POPPING SENSATION. THE DISLOCATION WAS TREATED WITH A CLOSED REDUCTION. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. EVENT DATE (B)(6) 2018: CLINIC NOTE INDICATES THE PATIENT EXPERIENCED A SECOND DISLOCATION OF THE RIGHT HIP AFTER TRYING TO MANUALLY ADDUCT THE RIGHT LEG WHILE SITTING. THE DISLOCATION WAS AGAIN TREATED WITH A CLOSED REDUCTION. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THIS DISLOCATION AND TREATMENT IS A CONTINUATION OF THE PREVIOUS DISLOCATION DATED (B)(6) 2018. CLINIC NOTES DATED (B)(6) 2018: FOLLOW-UP VISITS S/P DISLOCATION X 2 FOLLOWING RIGHT HIP THA REVISION. RADIOGRAPHS IDENTIFY A WELL-FIXED AND APPROPRIATELY ALIGNED RIGHT THA. THE PATIENT SEES IMPROVEMENT IN PAIN, FUNCTION, AND PARTICIPATION IN ADLS. DOI (NON- MOM): (B)(6) 2018. DOE: (B)(6) 2018: DISLOCATION TREATED WITH CLOSED REDUCTION RIGHT HIP.

    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. CONCOMITANT MEDICAL PRODUCTS: ASR ACETABULAR CUPS 56 999800756 LOT: 1831565; ASR UNI FEMORAL IMPL SIZE 49 999890249 LOT: 2090373; ADAPTER SLEEVES 12/14 +8 999800318 LOT: 2071790. ATTORNEY.

    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 IS SEEKING LEGAL ACTION. DOI: (B)(6) 2006; DOR: NONE REPORTED; (RIGHT SIDE). PATIENT IS A RESIDENT OF (B)(6). UPDATE (B)(6) 2018. (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF ASR LITIGATION RECORD. LITIGATION ALLEGES PAIN, WEAKNESS, DIFFICULTY WITH SIMPLE DAILY LIVING ACTIVITIES, HIGH METAL IONS, INJURY, SUFFERING AND EMOTIONAL DISTRESS. DOI: (B)(6) 2006; DOR: (B)(6) 2018; RIGHT HIP.

    Description of Event or Problem · 1

    MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED METAL ION LEVELS. INTRAOPERATIVELY, THERE WAS EVIDENCE OF METALLOSIS. THERE IS NO EVIDENCE OF LOOSENING OF THE FEMORAL COMPONENT. THE STEM WAS RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567458 CORAIL2 LAT COXA VARA SIZE 13 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM LZO DEPUY FRANCE SAS 3003895575 3L93713 1867515 10603295168904
    567465 CORAIL2 LAT COXA VARA SIZE 13 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM LZO DEPUY FRANCE SAS 3003895575 3L93713 1867515 10603295168904

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention ADAPTER SLEEVES 12/14 +8| ASR ACETABULAR CUPS 56| ASR UNI FEMORAL IMPL SIZE 49