BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 LAT COXA VARA SIZE 12

    MDR report key: 7832298 · Received August 30, 2018

    Report

    Report Number
    1818910-2018-68119
    Event Type
    Injury
    Date Received
    August 30, 2018
    Date of Event
    November 19, 2012
    Report Date
    August 8, 2018
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWL
    UDI-DI
    10603295168898
    PMA / PMN Number
    K123991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). 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. INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. PER INTERNAL PROCEDURES, THE EVENT INFORMATION AND ANY INVESTIGATIONAL INPUTS RECEIVED AS PART OF REQUIRED FOLLOW UP WERE REVIEWED. FOR THIS INVESTIGATION, NO IMMEDIATE ACTION WAS REQUIRED AS NO ALLEGED DEFICIENCY WITH THE DEVICE WAS IDENTIFIED. MONITOR: EXEMPT PER WI-7915 - KNOWN POSSIBLE COMPLICATION OF JOINT REPLACEMENT SURGERY. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. IN ORDER TO DETERMINE IF A LOT RELATED ISSUE WAS POSSIBLE, A WORLDWIDE COMPLAINT DATABASE SEARCH WAS PERFORMED. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND ADDITIONAL RELATED REPORTS AGAINST THE PROVIDED PRODUCT CODE, LOT NUMBER COMBINATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED. THE DHR ANALYSIS OF THE BATCH RETURNED SHOWS AN INITIAL CONFORMANCE OF THIS PRODUCT WITH REGARDS TO ITS SPECIFICATION. FOR THIS BATCH, THERE WAS NO DEVIATION. IT WAS RECORDED A FAILURE INVESTIGATION REPORT: 2009-109, CONCERNING ONE PART WITH A DEFECT OF APPEARANCE AFTER POLISHING AT SUBCONTRACTOR, THIS PART WAS REJECTED BECAUSE A REWORK WAS NOT POSSIBLE. THE REPORTED EVENT IS CONSIDERED ONE OF THE POSSIBLE COMPLICATIONS OF JOINT REPLACEMENT. INVESTIGATIONAL INPUTS WERE REQUESTED AS INDICATED PER INTERNAL PROCEDURES FOR THIS FAILURE MODE. THE COMPLAINT INFORMATION PROVIDED HAS BEEN REVIEWED FOR COMPLAINT CODING, MEDICAL DEVICE REPORTING, AND OTHER DATA REQUIRED BY THE COMPLAINT SYSTEM. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION, IF APPLICABLE, WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-7915 APPENDIX A. WITHOUT THE PHYSICAL COMPLAINT SAMPLE ASSOCIATED WITH THIS REPORT, IT WAS NOT POSSIBLE TO DETERMINE IF THE DEVICE FAILED TO MEET SPECIFICATIONS AT THE TIME IT WAS RELEASED FOR DISTRIBUTION. THE DEVICE ASSOCIATED WITH THIS EVENT WAS USED IN THE TREATMENT OF THE PATIENT AS PRESCRIBED BY THE PRESIDING SURGEON. FROM THE EVENT INFORMATION RECEIVED, IT WAS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP OF THE DEVICE TO THE REPORTED EVENT. NO EVIDENCE WAS FOUND INDICATING PRODUCT ERROR WAS A CONTRIBUTING FACTOR. THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: 5003643. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL.

    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.

    Description of Event or Problem · 1

    LITIGATION ALLEGES SEVERE PAIN, DISCOMFORT, INFLAMMATION, AND ELEVATED LEVELS OF COBALT CHROMIUM METAL IONS AND PARTICLES IN THE BLOOD AND TISSUE SURROUNDING THE IMPLANT. UPDATE 4/12/2013- PFS AND MEDICAL RECORDS RECEIVED FROM LEGAL. PART/LOT PROVIDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. NEW UNITY RECORD CREATED IN ORDER TO UPDATE ETQ COMPLAINT NUMBER (B)(4). UPDATE 25 APR 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS RECEIVED. THERE ARE NO NEW ALLEGATIONS. ADDED FIRM AND UPDATED PATIENT'S INITIALS. ADDED STEM 3L93712, LOT # 5003643. DOI: (B)(6) 2010; DOR: NONE REPORTED; (RIGHT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674236 CORAIL2 LAT COXA VARA SIZE 12 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM KWL DEPUY FRANCE SAS - 3003895575 5003643 10603295168898

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other