BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM STM STD 36+12L 13X18

    MDR report key: 9794405 · Received March 5, 2020

    Report

    Report Number
    1818910-2020-06987
    Event Type
    Injury
    Date Received
    March 5, 2020
    Date of Event
    January 29, 2016
    Report Date
    February 18, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    UDI-DI
    10603295178224
    PMA / PMN Number
    K851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. DEVICE HISTORY LOT 1200898. THE DHR REVIEW BY THE MANUFACTURING SUPPLIER FOUND NO RELATED DEVIATION OR ANOMALY THAT WOULD CONTRIBUTE TO THE REPORTED ALLEGATION. DEVICE HISTORY BATCH NULL DEVICE HISTORY REVIEW NULL.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. 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

    PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD, THE PATIENT WAS REVISED DUE TO FAILED RIGHT TOTAL HIP ARTHROPLASTY. PATIENT EXPERIENCED PAIN, WEAKNESS, ELEVATED METAL IONS AND LARGE FLUID COLLECTION, AND ADVERSE TISSUE REACTION. REVISION NOTES STATED THAT THERE WAS 100 ML OF CLOUDY YELLOW FLUID COLLECTED. THERE WAS SIGNIFICANT DAMAGE TO THE MUSCULAR TISSUE AROUND THE HIP, MILD SCRATCHES AT THE FEMORAL HEAD AND THE INSERT AND WAS REMOVED. DOR: (B)(6) 2004, DOR: (B)(6) 2016 (RIGHT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258260 SROM STM STD 36+12L 13X18 S-ROM HIP SYSTEM : HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US 56-3618 1200898 10603295178224

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention PINNACLE 100 ACET CUP 52MM| S-ROM*SLEEVE PRX ZTT, 18B-LRG