BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY LG STAT LNG LT 13.5MM

    MDR report key: 7564088 · Received June 3, 2018

    Report

    Report Number
    1818910-2018-61179
    Event Type
    Injury
    Date Received
    June 3, 2018
    Date of Event
    April 12, 2013
    Report Date
    May 4, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    K000207
    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. PRODUCT COMPLAINT # (B)(4). 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 : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    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.

    Description of Event or Problem · 1

    UPDATED EXPIRATION DATES OF IMPACTED PRODUCTS. ADDED ACCOUNT NAME AND LAW FIRM. DOI: (B)(6) 2003; DOR: (B)(6) 2007; (LEFT HIP).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN AND EXTREME WEAKNESS IN THEIR HIP AND QUADRICEP. UPDATE: 9/9/2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. THE RECORDS INDICATE THAT THE PATIENT WAS REVISED BECAUSE OF PAIN, METALLOSIS, AND LOOSE CUP. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE AD 04 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PINNACLE PPF RECORD. IN ADDITION TO WHAT PREVIOUS ALLEGED, PPF ALLEGES METAL WEAR AND ELEVATED METAL IONS. ADDED STEM (PART: 152050050:K000207/LPH). PATIENT REVISION HOSPITAL, UDI, MANUFACTURING DATES, EXPIRATION DATE, PATIENT HARM WERE UPDATED AS WELL. DOI: (B)(6) 2003; DOR: (B)(6) 2007; LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406385 PRODIGY LG STAT LNG LT 13.5MM PRODIGY HIP STEM : HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS, INC. 1818910 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention