BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA PS CEM FEM SZ3 L

    MDR report key: 4192632 · Received October 22, 2014

    Report

    Report Number
    1818910-2014-30427
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    June 16, 2014
    Report Date
    September 23, 2014
    Manufacturer
    DEPUY (IRELAND) 9616671
    Product Code
    JWH
    PMA / PMN Number
    PK073529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED AND ARE PRESUMED YET IMPLANTED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. PATIENT MEDICAL RECORDS WERE PROVIDED. REVIEW OF THE SUPPLIED MEDICAL RECORDS CONFIRMED EXTENSIVE ARTHROFIBROSIS OF THE EXTENSOR MECHANISM WITH A SIGNIFICANT AMOUNT OF SCAR TISSUE. THE MEDICAL RECORDS SUGGEST EXCESSIVE SCAR TISSUE WAS THE CAUSE OF THE PATELLAR CLUNKING AND PAIN AT THE TIME. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. NO EVIDENCE WAS FOUND OF PRODUCT CONTRIBUTION TO THE REPORTED EVENT AND THE NEED FOR CORRECTIVE ACTION IS 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

    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. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS REVISED BECAUSE OF PAIN, SWELLING, AND NUMBNESS AND COLDNESS IN HER TOE. DOI: (B)(6) 2011- DOR: NOT REVISED (LEFT KNEE). UPDATE REC¿D (B)(6) 2014 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT UNDERWENT AN ARTHROSCOPY ON (B)(6) 2013 TO ADDRESS ADHESIONS. THERE IS NO INDICATION THE PATIENT HAS BEEN REVISED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014. UPDATE REC¿D (B)(6) 2014- PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. THE PATIENT'S OFFICE VISIT ON (B)(6) 2013 INDICATES THE PATIENT'S CHRONIC PAIN WAS FELT TO BE RELATED TO ARTHROFIBROSIS AND SCARRING OF THE EXTENSOR MECHANISM, THEREFORE WAS TAKEN TO SURGERY FOR AND ARTHROSCOPY. THE PATIENT'S FEMORAL COMPONENT AND PATELLAR COMPONENT ARE BEING REPORTED AT THIS TIME. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671381 SIGMA PS CEM FEM SZ3 L KNEE FEMORAL COMPONENT JWH DEPUY (IRELAND) 9616671 3340748

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention