BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*SIGMA C/R NPOR FEM LT SZ5

    MDR report key: 8499515 · Received April 10, 2019

    Report

    Report Number
    1818910-2019-90294
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Date of Event
    March 29, 2019
    Report Date
    April 2, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JWH
    UDI-DI
    10603295231974
    PMA / PMN Number
    K943462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: FOLLOWING INVESTIGATION BY THE MANUFACTURING SITE, IT WAS CONFIRMED THAT A HAIR HAD BEEN IDENTIFIED INSIDE THE PRODUCT PACKAGING. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO ANOMALIES AND A REVIEW OF PREVIOUS COMPLAINTS IDENTIFIED THAT THE NUMBER OF SIMILAR COMPLAINTS IDENTIFIED THE OCCURRENCE RATE TO BE REMOTE, AT (B)(4). PACKAGING OPERATORS WERE NOTIFIED OF THE INCIDENT AND FURTHER AWARENESS TRAINING WAS COMPLETED. THE COMPLAINT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE REVIEWED AND FURTHER INVESTIGATION COMPLETED AS REQUIRED. DEVICE HISTORY LOT : 053510 DEVICE HISTORY REVIEW: DHR REVIEW. PRODUCT CODE 960005, PFC*SIGMA C/R NPOR FEM LT SZ5, WORK ORDER (B)(4) WAS MANUFACTURED ON 19/FEBRUARY/2019. (B)(4) PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE WAS NO NCS/DEVIATION/CAPA ASSOCIATED IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.  IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    CUSTOMER IS COMPLAINING A HAIR INSIDE THE INNER STERILE PACKAGE. NO SURGERY DELAY, NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292475 PFC*SIGMA C/R NPOR FEM LT SZ5 SIGMA KNEE PRIMARY : KNEE FEMORAL JWH DEPUY ORTHOPAEDICS, INC. 1818910 9053510 10603295231974

    Patients

    Seq Age Sex Outcome Treatment
    1