BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP CV TB/IN S3 10.0

    MDR report key: 4553122 · Received February 27, 2015

    Report

    Report Number
    1818910-2015-14791
    Event Type
    Injury
    Date Received
    February 27, 2015
    Date of Event
    June 3, 2007
    Report Date
    January 22, 2015
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND ONE RELATED INCIDENT FOR PRODUCT CODE: 962031 LOT CODE: 2307599. A DHR ANALYSIS WAS CONDUCTED AND DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. 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

    CLINICAL DER RECEIVED. PATIENT WAS TREATED FOR AND LYSIS OF ADHESIONS AND LATER REVISED FOR INSTABILITY. UPDATE REC¿D 01/22/2015 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. THE MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. ACCORDING TO THE PATIENT'S MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS LIGAMENT LAXITY, MARKED HYPEREXTENSION WITH MODERATE TO SEVERE MEDIAL LATERAL LAXITY, EFFUSIONS AND PAIN. THE INSERT SHOWED NO SIGNS OF POLYETHYLENE WEAR OR FAILURE ON THE TOP SIDE OR BACKSIDE. THE INSERT IS BEING REPORTED AT THIS TIME FOR THE PATIENT'S PAIN. THE COMPLAINT WAS UPDATED ON: 02/26/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140168 PFC SIGMARP CV TB/IN S3 10.0 KNEE FEMORAL COMPONENT NJL DEPUY IRELAND 9616671 2307599

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention