BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.7MM COCR CABLE WITH TI CRIMP 750MM-STERILE

    MDR report key: 8570372 · Received May 1, 2019

    Report

    Report Number
    2939274-2019-57760
    Event Type
    Injury
    Date Received
    May 1, 2019
    Report Date
    April 3, 2019
    Manufacturer
    RTI SURGICAL
    Product Code
    JDQ
    UDI-DI
    10886982250728
    PMA / PMN Number
    K992616
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT MANUFACTURING LOCATION: SUPPLIER - PIONEER SURGICAL / INSPECTION AND RELEASE BY: MONUMENT PART NUMBER: 611.105.01S, 1.7MM COCR CABLE WITH TI CRIMP 750MM-STERILE LOT NUMBER: P102159 (STERILE) PURCHASED FINISHED GOODS TRAVELERS MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEETS, INCOMING FINAL INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFICATES OF CONFORMANCE RECEIVED FROM PIONEER SURGICAL DATED 07-OCT-2011, 31-OCT-2011 AND 07-NOV-2011 WERE REVIEWED AND DETERMINED TO BE CONFORMING. STERILIZATION DOCUMENTATION SUPPLIED TO PIONEER BY STERIS ISOMEDIX WAS REVIEWED AND DETERMINED TO BE CONFORMING. NOTE: NO EXPIRATION DATES WERE PROVIDED WITH THE STERILITY DOCUMENTS. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT UNDERWENT FIRST REVISION LEFT HIP DUE TO ALLEGED INFECTION REQUIRING IV ANTIBIOTICS. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE DEPUY PINNACLE HIP SYSTEM (CUP, LINER, HEAD AND STEM) ON (B)(6) 2007. DURING THE REVISION SURGERY, THE DEPUY PINNACLE HIP SYTEM (CUP, LINER, HEAD AND STEM) WERE REMOVED, AND REPLACED WITH ZIMMER (CUP, LINER, HEAD AND STEM) ALONG WITH THE THREE (3) COBALT CHROME CERCLAGE CABLE WITH CRIMP TO SECURE IMPLANTS. IT WAS NOTED THAT AFTER THE REVISION THERE WAS STILL INFECTION REQUIRING IV ANTIBIOTICS. THE PROCEDURE AND PATIENT OUTCOMES WERE UNKNOWN.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. OCCUPATION: INITIAL REPORTER IS LAWYER. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION ON (B)(6) 2012 DUE TO INFECTION REQUIRING IV ANTIBIOTICS. THE PATIENT HAD AN ORIGINAL IMPLANT OF THREE (3) COBALT CHROMIUM CABLE TITANIUM CRIMP STERILE ON (B)(6) 2007. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 1.7MM COCR CABLE WITH TI CRIMP. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363708 1.7MM COCR CABLE WITH TI CRIMP 750MM-STERILE CERCLAGE FIXATION JDQ RTI SURGICAL 611.105.01S P102159 10886982250728

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention