BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK KNEE TIBIAL INSERT SIGMA

    MDR report key: 15410004 · Received September 13, 2022

    Report

    Report Number
    1818910-2022-17750
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    June 1, 2021
    Report Date
    September 13, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. 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 · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. DEVICE HISTORY LOT : A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    "THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LE MASTERS T, JOHNSON S, JERALDO PR, GREENWOOD-QUAINTANCE KE, CUNNINGHAM SA, ABDEL MP, CHIA N, PATEL R. COMPARATIVE TRANSCRIPTOMIC ANALYSIS OF STAPHYLOCOCCUS AUREUS ASSOCIATED WITH PERIPROSTHETIC JOINT INFECTION UNDER IN VIVO AND IN VITRO CONDITIONS. J MOL DIAGN. 2021 AUG;23(8):986-999. DOI: (B)(4). EPUB 2021 JUN 5. PMID: 34098085; PMCID: PMC8351120. OBJECTIVE AND METHODS THE GOAL OF THIS STUDY WAS TO COMPARE THE TRANSCRIPTOMIC PROFILES OF EIGHT S. AUREUS PJI CASES UNDER IN VIVO AND IN VITRO CONDITIONS USING WHOLE TRANSCRIPTOME SEQUENCING APPLIED TO MATERIALS DISLODGED FROM EXPLANTED DEVICES THROUGH SONICATION. THE AUTHORS STUDY 8 PATIENTS WITH EXISTING S. AUREUS INFECTIONS AROUND A TOTAL JOINT ARTHROPLASTY. PATIENT 2 HAD AN ASR XL/SUMMIT THA AND PATIENT 8 HAD A SIGMA CR TKA. THE REMAINING 6 PATIENTS HAD COMPETITOR CONSTRUCTS AND WILL BE EXCLUDED FROM THIS COMPLAINT. THE TREATMENT FOR THE INFECTIONS WAS IV ANTIBIOTICS AND EVENTUAL REVISION. THIS COMPLAINT WILL CAPTURE THE 2 PATIENTS WITH DEPUY TJAS. PATIENT 8: 69-YO FEMALE PATIENT RECEIVED A REVISION OF AN UNKNOWN KNEE TO TREAT PERSISTENT INFECTION UNSUCCESSFULLY TREATED WITH IV ANTIBIOTICS 314 DAYS AFTER PRIMARY IMPLANTATION. THE PFC SIGMA CR FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT WERE REVISED TO UNKNOWN PRODUCTS. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE MANUFACTURER OF THE CEMENT AND/OR IF THE PATELLA WAS RESURFACED. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1970620 UNK KNEE TIBIAL INSERT SIGMA KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention UNKNOWN ANTIBIOTIC CEMENT