BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ6 STD OFF

    MDR report key: 7780888 · Received August 14, 2018

    Report

    Report Number
    1818910-2018-66559
    Event Type
    Injury
    Date Received
    August 14, 2018
    Date of Event
    April 12, 2018
    Report Date
    July 20, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295059370
    PMA / PMN Number
    K001991
    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 PROVISION DEPUY SYNTHES 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. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. CORRECTIVE ACTION WAS NOT INDICATED. 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

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(6).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN IN HIS HIP AND LEG, ELEVATED CHROMIUM COBALT LEVELS, LIMITED MOBILITY, CLICKING SOUNDS, AND LOSS OF FEELING. DOI: (B)(6) 2009- DOR: NONE REPORTED (RIGHT SIDE). PATIENT IS A RESIDENT OF (B)(6). UPDATE - (B)(6) 2012 - MEDICAL RECORDS WERE RECEIVED FROM LEGAL. PART/LOT INFORMATION WAS IDENTIFIED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE (B)(6) 2018: WPC (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PINNACLE PPF AND IMPLANT STICKER. PPF HAS NO NEW ALLEGATIONS REPORTED. IT WAS STATED THAT THE CUP, LINER AND HEAD WERE REVISED ON (B)(6) 2018. ADDED STEM PART 15700120, LOT DK6B41, (K001991/LPH); AND CUP PART 121732058, LOT DS9G51000 (K071784/LPH); AND SCREWS PART 121715500: (K983014/LPH); PART 121725500 (K983014/LPH). THE PATIENT DOB, LAWYER FIRM, REVISION HOSPITAL, AGE, AND EXPIRATION DATE, DOE WERE UPDATED AS WELL. DOI: (B)(6) 2009; DOR: (B)(6) 2018; RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624412 SUMMIT POR TAPER SZ6 STD OFF SUMMIT HIP STEM : HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US DK6B41 10603295059370

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention