BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX20MM

    MDR report key: 4179154 · Received October 16, 2014

    Report

    Report Number
    1818910-2014-30001
    Event Type
    Injury
    Date Received
    October 16, 2014
    Date of Event
    July 26, 2012
    Report Date
    March 29, 2013
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS ¿ REG.
    Product Code
    NDJ
    PMA / PMN Number
    PK983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.FOLLOW-UP WITH THE COMPLAINT HAS BEEN CONDUCTED FOR THE CATALOG NUMBER AND LOT NUMBER AND THIS INFORMATION IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES 442045, C445256, EC7E31, 442137, 2844087 AND ER7GE1. BASED ON THE INABILITY TO FIND ANY OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODES IT IS NOT UNREASONABLE TO CONCLUDE THAT THERE ARE NO ANOMALIES WITH REGARD TO MANUFACTURING OR INSPECTION CONTAINED IN THE DEVICE HISTORY RECORDS THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE FOR THE UNKNOWN LOT CODE(S). A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ONE ADDITIONAL REPORTED INCIDENT AGAINST LOT CODES 419128 AND 2932406 SINCE THEIR RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES.DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR THE ORIGINAL COMPLAINT ¿ PATIENT WAS REVISED TO ADDRESS PAIN. DOI (B)(6) 2011 - DOR (B)(6) 2012 (RIGHT HIP). UPDATE REC'D 3/29/2013- PPD AND MEDICALRECORDS RECEIVED. THIS COMPLAINT IS NOW LEGAL. AFTER REVIEW OF THE MEDICALRECORDS ALL OF THE OTHER IMPLANTS ARE BEING ADDED TO THE COMPLAINT AS THEYCANNOT BE EXCLUDED AS THE CAUSE PAIN AS THE COMPLAINT IS NOW LEGAL. THERE ISNO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.THE COMPLAINT WAS UPDATED ON: (B)(6) 2014

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659319 PINN CAN BONE SCREW 6.5MMX20MM HIP OTHER IMPLANT-SCREW NDJ DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS ¿ REG. 442045

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention