BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL TRAY

    MDR report key: 8971382 · Received September 6, 2019

    Report

    Report Number
    1818910-2019-103380
    Event Type
    Injury
    Date Received
    September 6, 2019
    Report Date
    August 16, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RECEIVED FOR EXAMINATION. 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, 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

    LITERATURE ARTICLE RECEIVED TITLED, " ALL-POLYETHYLENE TIBIAL COMPONENTS IN OBESE PATIENTS ARE ASSOCIATED WITH LOW FAILURE AT MIDTERM FOLLOW-UP" WAS REVIEWED FOR MDR REPORTABILITY. BETWEEN 1996 AND 2002 378 KNEES (273 PATIENTS) WERE IMPLANTED WITH A CEMENTED ALL POLY TIBIAL (APT) COMPONENT (PFC/SIGMA). OF THE 273 PATIENTS, 90 PATIENTS (125 KNEES) WERE CHARACTERIZED AS OBESE. OF THOSE 90 PATIENTS, 24 PATIENTS (33 KNEES) DIED AND 13 PATIENTS (17 KNEES) WERE LOST DURING FOLLOW-UP BEFORE A MINIMUM OF 7 YEARS. THE FINAL STUDY PERTAINED TO 53 PATIENTS (75 KNEES). NO INFORMATION WAS PROVIDED REGARDING THE CEMENT AND OTHER IMPLANT (FEMORAL AND PATELLA) MANUFACTURERS. RESULTS PERTAINING TO APT: 5 KNEES (4 PATIENTS) HAD TIBIAL RADIOLUCENCIES-ALL OF WHICH WERE LESS THAN 1 MM AND NON-PROGRESSIVE. THERE WERE NO FEMORAL OR PATELLAR ZONES OF OSTEOLYSIS. 1 KNEE UNDERWENT A REVISION DUE TO INSTABILITY. IT SHOULD BE NOTED THE PATIENT HAD PREVIOUSLY EXPERIENCED A TRAUMATIC EVENT (FALL). REVISION OCCURRED 21 MONTHS AFTER PRIMARY OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766454 UNKNOWN KNEE TIBIAL TRAY KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS, INC. 1818910 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention