BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFCSIG POSTLIP INSERT SZ4 8MM

    MDR report key: 2961339 · Received February 14, 2013

    Report

    Report Number
    1818910-2013-12357
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    JWH
    PMA / PMN Number
    PK943462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR 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.

    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

    UPDATE REC'D 02/17/2016 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT HAD DEVELOPED POLY WEAR, OSTEOLYSIS, AND LOOSENING OF TIBIAL AND FEMORAL COMPONENTS. AT THIS TIME, THE PATIENT'S TIBIAL AND PATELLAR COMPONENTS ARE BEING ADDED TO THE COMPLAINT AND REPORTED. UPDATE REC'D 03/09/2016 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE NEWLY 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF PAIN, LOOSE FEMORAL COMPONENT AT THE BONE/CEMENT INTERFACE WITH DEPUY CEMENT. POLY WEAR OF THE LINER WAS NOTED.

    Description of Event or Problem · 1

    UPDATE REC'D 02/17/2016 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILLITY. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT HAD DEVELOPED POLY WEAR, OSTEOLYSIS, AND LOOSENING OF TIBIAL AND FEMORAL COMPONENTS. AT THIS TIME, THE PATIENT'S TIBIAL AND PATELLAR COMPONENTS ARE BEING ADDED TO THE COMPLAINT AND REPORTED. THE COMPLAINT WAS UPDATED ON: 03/07/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65623 PFCSIG POSTLIP INSERT SZ4 8MM KNEE INSERT JWH 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC 60291A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention