BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLT TS CER HD 12/14 36MM +1.5

    MDR report key: 6676743 · Received June 29, 2017

    Report

    Report Number
    1818910-2017-20361
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    March 25, 2016
    Report Date
    May 31, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LZO
    UDI-DI
    10603295033653
    PMA / PMN Number
    K071830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. ADDITIONAL NARRATIVE: 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 8162824. DEVICE HISTORY REVIEW A DEVICE HISTORY RECORD (DHR) REVIEW ON (B)(4) FOUND (B)(4) WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE ARE NO NC¿S OR DEVIATIONS ASSOCIATED WITH THIS LOT. 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

    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    ON MAY 31, 2017: LEGAL MEDICAL RECORDS RECEIVED. LITIGATION ALLEGES PAIN AND SUFFERS FROM THREE DISLOCATIONS WHICH CAUSED SEVERE DAMAGE TO THE FEMORAL ARTERY RESULTING IN THE ARTERY SHUTTING DOWN, EVENTUALLY CUTTING OFF THE BLOOD SUPPLY TO THE LEG LEADING TO COMPARTMENT SYNDROME REQUIRING SURGERY ON (B)(6) 2016 (MEDICAL RECORDS CONFIRM CORRECT DATE OF (B)(6) 2016). IT ALSO ALLEGES THE PATIENT EXPERIENCED PROGRESSIVE SENSORY LOSS AND THROMBOSIS OF THE FEMORAL ARTERY LEADING TO AMPUTATION OF HER LEG ON (B)(6) 2016 (MEDICAL RECORDS CONFIRM CORRECT DATE OF (B)(6) 2016). AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT UNDERWENT A RE-REVISION TO ADDRESS DISLOCATION AND INSTABILITY. RE-REVISION NOTES NOTED THE PRESENCE OF JOINT FLUID UPON ENTERING THE HIP. THE SURGEON TRIED TO PERFORM A DISLOCATION OF THE PATIENT BUT FOUND THAT THE PATIENT WAS EXTREMELY STABLE IN POSITION OF FLEXION, NEUTRAL ABDUCTION, AND INTERNAL ROTATION TO CLOSE TO 60 DEGREES AND IN A POSITION OF EXTERNAL ROTATION AND EXTENSION. IT WAS ALSO NOTED THAT THE PATIENT DID HAVE SOME INABILITY TO FLEX HER HIP THAT WAS POTENTIALLY SECONDARY TO A CONTUSION OF THE PSOAS MUSCULATURE VERSUS A RUPTURE WHICH OCCURRED AT THE TIME OF HER DISLOCATION. THE STEM AND LINER USED IS A NON-DEPUY PRODUCT. PATIENT UNDERWENT GUILLOTINE AMPUTATION OF THE RIGHT LEG AFTER RE-REVISION BUT THE DEPUY HEAD WAS NOT EXPLANTED, SO THIS WILL NOT BE REPORTED IN A NEW COM. ALL SUBSEQUENT FINDINGS AFTER THE RE-REVISION WILL BE INCORPORATED IN THIS COMPLAINT. THIS COMPLAINT WAS UPDATED ON: JUN 7, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457187 DLT TS CER HD 12/14 36MM +1.5 HIP FEMORAL HEAD LZO DEPUY ORTHOPAEDICS, INC. 1818910 8162824 10603295033653

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention