BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 11

    MDR report key: 8573328 · Received May 2, 2019

    Report

    Report Number
    1818910-2019-92252
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    August 7, 2017
    Report Date
    April 10, 2019
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWA
    UDI-DI
    10603295168775
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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 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. OCCUPATION: ATTORNEY. (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERED EXTREME PAIN, DISCOMFORT, SORENESS; MALAISE; SWELLING; LOSS OF ENERGY; IMMOBILIZATION AND BOTH ACUTE LOCALIZED DAMAGE TO TISSUE AND/OR BONE SURROUNDING THE ACETABULUM, SYSTEMIC INJURIES AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT. UPDATE AD 10 APR 2019: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS, PAIN, PSEUDOTUMOR AND PROSTHETIC JOINT INFECTION. AN IRRIGATION AND EXCISIONAL DEBRIDEMENT OF ILIACUS ABSCESS WAS DONE. OPERATIVE NOTE REPORTED VERY LARGE PSEUDOTUMOR WITH A THICK PSEUDOCAPSULE, THERE WERE ALSO A LARGE AMOUNT OF NECROTIC PHLEGMON AND A LARGE AMOUNT OF PURULENCE. NO LAB RESULT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367758 CORAIL2 STD SIZE 11 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM KWA DEPUY FRANCE SAS - 3003895575 3L92511 2199862 10603295168775

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention