BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 11

    MDR report key: 3971825 · Received July 31, 2014

    Report

    Report Number
    1818910-2014-24722
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    March 14, 2012
    Report Date
    July 10, 2014
    Manufacturer
    DEPUY FRANCE SAS
    Product Code
    LZO
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODE BF9FF1000. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ONE ADDITIONAL REPORTED INCIDENT AGAINST LOT CODES 2215520 AND 2417439 SINCE THEIR RELEASE FOR DISTRIBUTION; HOWEVER, A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    (B)(4). REASON FOR ORIGINAL COMPLAINT - COMPLAINANT, MALE, (B)(6), UNDERWENT RIGHT HIP TRANSPLANT SURGERY IN 2007. IN EARLY 2010 COMPLAINANT BEGAN TO EXPERIENCE PAIN AT THE HIP JOINT. CONDITION PROGRESSED THROUGH REMAINDER OF THE YEAR AND INTO 2011. PAIN BECAME SO UNBEARABLE HE RETURNED TO HIS ATTENDING SURGERY FOR EVALUATION. TESTS REVEALED HIP IMPLANT FAILURE, THE BALL AND JOINT (METAL TO METAL HAD LOOSENED AND SUSPECTED TO CAUSE THE PAIN AND WALKING DIFFICULTY. COMPLAINANT OBTAINED HIS SURGICAL RECORDS FROM (B)(6) AND CONFIRMED THAT A DEPUY ASR XL ACETABULAR REPLACEMENT SYSTEM (METAL ON METAL) WAS USED. DEVICE PROVED DEFECTIVE AND DANGEROUS THAT COMPANY INITIATED VOLUNTARY RECALL IN 8/2010. SUBJECT ITEMS WERE IMPLANTED IN COMPLAINANT. COMPLAINANT'S CURRENT HISTORY: EXTREME DIFFICULTY WALKING, PERSISTENT PAIN IN HIP JOINT AREA. FOLLOW UP SURGERY BEING SCHEDULED IN (B)(6) 2012 TO REPLACE THE DEFECTIVE SYSTEM. DR (B)(6) WILL PERFORM REVISION SURGERY. HOSPITAL AND MEDICAL RECORDS AVAILABLE FOR THIS COMPLAINT. COMPLAINANT NOTIFIED COMPANY AND WAS TOLD TO SCHEDULE SURGERY BEFORE FILING COMPENSATION CLAIM. UPDATE: LITIGATION PAPERS RECEIVED (B)(4) 2013. LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM SWELLING, INFLAMMATION, INFECTION, AND DAMAGE TO SURROUNDING BONE AND TISSUE, MULTIPLE DISLOCATIONS AND LACK OF MOBILITY. DATE OF IMPLANT AND DATE OF REVISION HAVE ALSO BEEN PROVIDED. THE MDR DECISION IS BEING REVERSED AND PRODUCTS REPORTED. THE COMPLAINT HAS BEEN UPDATED ON (B)(4) 2013. UPDATE REC'D (B)(4) - PFS AND MEDICAL RECORDS RECEIVED. A CORRECT DOR WAS GIVEN. AFTER REVIEW OF MEDICAL RECORDS THE PRIMARY OPERATIVE NOTE AND STICKER SHEET CONFIRMED THE PATIENT DIDN¿T HAVE ASR IMPLANTED AS ALLEGED. THE REVISION OPERATIVE NOTE ALSO INDICATED A LOOSE STEM SO THE STEM IS BEING ADDED TO THE COMPLAINT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446695 CORAIL2 NON COL HO SIZE 11 HIP FEMORAL STEM/SLEEVE LZO DEPUY FRANCE SAS 1856303

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention