BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL INSERT

    MDR report key: 9407683 · Received December 4, 2019

    Report

    Report Number
    1818910-2019-119831
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    May 3, 2016
    Report Date
    November 15, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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: 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. 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. (B)(4).

    Description of Event or Problem · 1

    "LITERATURE ARTICLE ""ARTHROPLASTY FOR TENOSYNOVIAL GIANT CELL TUMORS"" (2016) BY FLOORTJE G M VERSPOOR ET AL. PUBLISHED BY ACTA ORTHOPAEDICA DOI 10.1080/17453674.2016.1205168 WAS REVIEWED. THE ARTICLE PURPOSE: TO ANALYZE THE RESULTS OF ARTHROPLASTY IN PATIENTS WITH T-GCT. THE ARTICLE REPORTS: THE AUTHORS IDENTIFIED 141 T-GCT PATIENTS AND, OF THESE, 17 RECEIVED AN ARTHROPLASTY PROCEDURE. OF THESE 17, 12 OF THEM RECEIVED A TKA. THERE WERE ONLY TWO PATIENTS THAT SUFFERED FROM COMPLICATIONS. ONE PATIENT WITH NEUROPATHIC PAIN WHO UNDERWENT NEUROLYSIS FOR TREATMENT. THE OTHER PATIENT SUFFERED FROM JOINT STIFFNESS WHO WAS TREATED WITH MUA. THIS LAST PATIENT ALSO DEVELOPED TIBIAL COMPONENT LOOSENING 6 YEARS POST-OPERATION AND UNDERWENT SUBSEQUENT REVISION SURGERY. CEMENT WAS USED ON BOTH OF THESE PATIENTS ALTHOUGH THE MANUFACTURER WAS NOT DISCLOSED. THE PATELLA WAS REPLACED ONLY IN THE PATIENT WITH THE NEUROPATHIC PAIN. DEPUY PRODUCTS INVOLVED: PFC SIGMA. COMPLICATIONS: PAIN (1), SURGICAL INTERVENTION (1)". THIS IS TO CAPTURE THE ADVERSE EVENTS ASSOCIATED WITH THE (B)(6) YEAR OLD FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204228 UNKNOWN KNEE TIBIAL INSERT KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention