BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*SIGMA C/R NPOR FEM LT SZ 4

    MDR report key: 9530852 · Received December 30, 2019

    Report

    Report Number
    1818910-2019-124888
    Event Type
    Malfunction
    Date Received
    December 30, 2019
    Date of Event
    December 7, 2019
    Report Date
    December 9, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295231967
    PMA / PMN Number
    K943462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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 : THE DEVICE WAS REVIEWED BY THE MANUFACTURER SUZHOU AND A REPORT WAS RECEIVED STATING FAILURE MODE CONFIRMED. ROOT CAUSE ATTRIBUTED TO DEVICE MANUFACTURING. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : PRODUCT CODE 960004, LOT NO. D19082255 WAS MANUFACTURED ON 22-AUG-2019. 24 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION 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

    PRODUCT COMPLAINT # (B)(4). 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

    COMPLAINT IS RELATED TO PRODUCT ONLY. THERE WAS NO SURGICAL INTERVENTION OR ADVERSE EVENT, AS IT WAS AN ISSUE DURING SHIPPING.

    Description of Event or Problem · 1

    THE TEAM TODAY BROUGHT BE AN IMPLANT THAT THEY WERE UNABLE TO USE AS THEY WERE UNABLE TO REMOVE FROM THE PACKAGING AND MAINTAIN THE STERILITY. THE OUTER PACKING APPEARS 'MELTED' AND PARTLY FUSED/COMPRESSED TO THE INNER SECTION TO THE INNER PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327967 PFC*SIGMA C/R NPOR FEM LT SZ 4 SIGMA KNEE PRIMARY : KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US 96-0004 D19082255 10603295231967

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention