BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX40MM

    MDR report key: 4052121 · Received September 2, 2014

    Report

    Report Number
    1818910-2014-27069
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    May 27, 2010
    Report Date
    August 1, 2014
    Manufacturer
    RAYNHAM
    Product Code
    NDJ
    PMA / PMN Number
    PK983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    ADDED: UDI. 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

    LEGAL CLAIM RECEIVED. UPDATE REC'D (B)(6) 2014 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND SYMPTOMS OF A LOOSE IMPLANT. UPDATE REC'D (B)(6) 2014- PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. AFTER REVIEW OF THE MEDICAL RECORDS THE PRIMARY OPERATIVE NOTE INDICATED THAT THE PATIENT HAD A POLY INSERT IMPLANTED, NOT METAL ON METAL. ALL PARTS ARE NOW BEING REPORTED AS THEY CANNOT BE EXCLUDED AS THE CAUSE OF PAIN. THE REVISION OPERATIVE NOTE WASN¿T INCLUDED SO IT IS UNKNOWN WHAT IMPLANT WAS ACTUALLY LOOSE. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(6)2014.

    Description of Event or Problem · 1

    PPF AND STICKER SHEETS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES FRACTURE OF THE COMPONENT. HOWEVER, IT WAS NOT SPECIFIED WHICH IMPLANTS WERE REMOVED AND FRACTURED. ADDED UNKNOWN HIP IMPLANT TO CODE THE IMPLANT FRACTURE. DOI: (B)(6) 2010- DOR: (B)(6) 2010, (RIGHT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534829 PINN CAN BONE SCREW 6.5MMX40MM HIP OTHER IMPLANT NDJ RAYNHAM 416650

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention