BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA FEM ADAPTER NEUTRAL BOLT

    MDR report key: 9637162 · Received January 28, 2020

    Report

    Report Number
    1818910-2020-03181
    Event Type
    Injury
    Date Received
    January 28, 2020
    Date of Event
    January 15, 2020
    Report Date
    January 15, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295233930
    PMA / PMN Number
    K0605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. H10 ADDITIONAL NARRATIVE: CORRECTED: H6. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. 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

    THE PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING WAS EXPLANTED AND A KASM ANTIBIOTIC SPACER WAS IMPLANTED. THERE IS NO FURTHER PATIENT INFORMATION AVAILABLE. HERE ARE THE FINAL 4 EXPLANTED IMPLANTS: 96-0901, LOT #D39FB4, 96-0901, LOT #H19755, 96-0908, LOT #HH7455, 96-0908, LOT # H08683. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98853 SIGMA FEM ADAPTER NEUTRAL BOLT SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY JWH DEPUY ORTHOPAEDICS INC US 96-0783 J4327T 10603295233930

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention