BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIG RPF INS SZ 4 10MM

    MDR report key: 2860870 · Received December 6, 2012

    Report

    Report Number
    1818910-2012-83221
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS FOR MDR: UPDATE AUGUST 26, 2015: PATIENT MEDICAL RECORDS AND X-RAYS RECEIVED. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE TO BE REVIEWED, IT IS NOT POSSIBLE TO DETERMINE IF THE COMPLAINT IS PRODUCT RELATED. X-RAYS WERE REVIEWED, AND NO EVIDENCE INDICATING A DEVICE NONCONFORMANCE WAS FOUND. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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.

    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 IS A DUPLICATE REPORT OF 1818910-2013-18401. THIS REPORT, 1818910-2012-83221, WILL BE KEPT FOR INVESTIGATION PURPOSES. A SEPARATE FOLLOW-UP REPORT WILL BE SUBMITTED TO REJECT 1818910-2013-18401. DEPUY STILL CONSIDERS THE INVESTIGATION TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED DEVICE DID NOT REVEAL ANY EVIDENCE OF PRODUCT FAILURE. RESEARCH OF THE SUBMITTED DEVICE CONFIRMED IT CONTAINS NICKEL ELEMENTS. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. NO INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED PATIENT NICKEL ALLERGY. NO EVIDENCE WAS FOUND OF PRODUCT ERROR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS NICKEL ALLERGY. THE TIBIAL TRAY WAS ALSO REPORTED TO BE LOOSE AT THE CEMENT/BONE INTERFACE; HOWEVER, THE MANUFACTURER OF THE CEMENT USED AT THE TIME OF ORIGINAL IMPLANTATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIG RPF INS SZ 4 10MM TIBIAL KNEE INSERT NJL 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC B2XM64000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention