BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX25MM

    MDR report key: 7780414 · Received August 14, 2018

    Report

    Report Number
    1818910-2018-66519
    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
    10603295009900
    PMA / PMN Number
    K983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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). INVESTIGATION SUMMARY: 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. 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

    PRODUCT COMPLAINT # (B)(4). 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

    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 12/17/2012 - 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 20 JUN 2018: (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
    622792 PINN CAN BONE SCREW 6.5MMX25MM BONE SCREWS AND PINS : SCREWS LPH DEPUY ORTHOPAEDICS INC US 413407 10603295009900

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention