BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*SIGMA C/R NPOR FEM RT SZ 3

    MDR report key: 9362701 · Received November 22, 2019

    Report

    Report Number
    1818910-2019-117578
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    October 25, 2019
    Report Date
    October 28, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JWH
    UDI-DI
    10603295232025
    PMA / PMN Number
    K943462
    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 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. H10 ADDITIONAL NARRATIVE: CORRECTED: H3 AND H6 PRODUCT COMPLAINT # ==> (B)(4) INVESTIGATION SUMMARY ==> THE PRODUCT WAS REVIEWED AND FAILURE MODE WAS CONFIRMED. ROOT CAUSE ATTRIBUTED TO PRODUCT DESIGN OF THE PACKAGING. 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 960013, LOT NO. D19073401 WAS MANUFACTURED ON 02-AUG-2019. 23 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION DEVICE HISTORY BATCH ==> NULL DEVICE HISTORY REVIEW ==> NULL 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

    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.

    Description of Event or Problem · 1

    SURGEON/STAFF OPENED PFC SIGMA 960013 LOT 19073401 ¿ DURING TKR SURGERY ¿ SURGEON INSPECTED IMPLANT WHICH WAS FOUND TO HAVE CONTAMINANT ON THE SIDE OF THE PROSTHESIS ¿ THE IMPLANT HAD NOT BEEN PLACED IN THE PATIENT ¿ THE IMPLANT WAS REMOVED FROM THE STERILE FIELD AND A REPLACEMENT WAS FOUND. IMPACT ON OPERATIVE TIME: 10 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158374 PFC*SIGMA C/R NPOR FEM RT SZ 3 SIGMA KNEE PRIMARY : KNEE FEMORAL JWH DEPUY ORTHOPAEDICS, INC. 1818910 96-0013 D19073401 10603295232025

    Patients

    Seq Age Sex Outcome Treatment
    1