BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA PS CEM FEM SZ2.5 R

    MDR report key: 9943551 · Received April 9, 2020

    Report

    Report Number
    1818910-2020-10559
    Event Type
    Injury
    Date Received
    April 9, 2020
    Date of Event
    March 23, 2020
    Report Date
    March 24, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295075127
    PMA / PMN Number
    K073529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. 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. 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

    IT WAS REPORTED THAT ON (B)(6) 2020, THE PRIMARY SURGERY WAS PERFORMED VIA TKA WITH THE SIGMA PS FEMORAL COMPONENT (P/N: 196050250) AND THE TIBIAL ROD (P/N: 866416) IN QUESTION. IN ROUTINE CHECKUP IN (B)(6), THE SURGEON CONFIRMED THAT THERE WAS NO PROBLEM, BUT ON (B)(6) 2020, THE PATIENT REPORTED KNEE SWELLING. THE SURGEON CONFIRMED THAT THE FEMORAL SUPRACONDYLAR FRACTURE OCCURRED. ON (B)(6) THE PATIENT UNDERWENT THE REVISION SURGERY BY REPLACING THE COMPONENT AND ROD WITH THE FEMORAL COMPONENT (P/N: 960087) AND STEM (P/N: 961731). NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407712 SIGMA PS CEM FEM SZ2.5 R SIGMA KNEE PRIMARY : KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US 1960-50-250 9173311 10603295075127

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention P.F.C.* FLUT TIB ROD 75 X 16MM| SIGMA PS CEM FEM SZ2.5 R