BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN.6.5 CANCELLOUS SCREW 25MM

    MDR report key: 2503448 · Received March 26, 2012

    Report

    Report Number
    1818910-2012-06947
    Event Type
    Injury
    Date Received
    March 26, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 1, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    NDJ
    PMA / PMN Number
    K983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. AN ENGINEERING EXPLANT REVIEW WAS PERFORMED. X-RAY IMAGES WERE NOT AVAILABLE FOR EXAMINATION. THERE ARE NO READILY IDENTIFIABLE INDICATIONS ON THE HEAD AND STEM, METAL LINER, ACETABULAR CUP, OR BONE SCREW THAT HELP TO IDENTIFY A CAUSE FOR INFECTION OR TO CONFIRM THAT INFECTION WAS PRESENT. THE CAUSE FOR THE REPORTED COMPLAINT OF INFECTION CANNOT BE DEFINITIVELY DETERMINED. A SEARCH OF THE COMPLAINTS DATABASES FINDS OTHER REPORTS AGAINST THE 2744557, 2704846 LOT CODES. PREVIOUS REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE REMAINING PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASES DID NOT SHOW ANY OTHER REPORTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS EXCEPT FOR THE PINN MTL INS. A SEARCH OF THE COMPLAINT DATABASES FOUND TWO OTHER REPORTS AGAINST THE (B)(4) PINNACLE MTL INS LOT 2744557. THE AS400 LOT TRACEABILITY FOR (B)(4) PINNACLE MTL INS LOT 2744557 SHOWS 9 OTHER UNITS HAVE BEEN DELIVERED / BILLED TO END CUSTOMERS AND PRESUMED IMPLANTED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. REPEATED ATTEMPTS TO OBTAIN THE MATRIX RELATED ITEMS AND COMPLAINT SAMPLES PROVED UNSUCCESSFUL. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND / OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PRIMARY DATE OF IMPLANT WAS (B)(6) 2009. THE PRODUCT SPECIALIST DOES NOT KNOW THE DATE OF THE FIRST REVISION. THE REASON FOR SECOND REVISION: LOOSENING OF THE IMPLANT, DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN.6.5 CANCELLOUS SCREW 25MM HIP NDJ DEPUY RAYNHAM B5TAW4000

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention