BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL INSERT

    MDR report key: 9330817 · Received November 15, 2019

    Report

    Report Number
    1818910-2019-116570
    Event Type
    Injury
    Date Received
    November 15, 2019
    Report Date
    October 31, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. 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. (B)(4).

    Description of Event or Problem · 1

    LITERATURE ARTICLE "SURVIVORSHIP AT MINIMUM 10-YEAR FOLLOW-UP OF A ROTATING PLATFORM, MOBILE-BEARING, POSTERIOR-STABILISED TOTAL KNEE ARTHROPLASTY" BY MICHELE ULIVI, LUCA ORLANDINI, VALENTINA MERONI, OLMO CONSONNI, VALERIO SANSONE PUBLISHED BY KNEE SURGERY SPORTS TRAUMATOLOGY ARTHROSCOPICS DOI 10.1007/S00167-014-3118-Y WAS REVIEWED. THE ARTICLE PURPOSE: TO EVALUATE THE LONG-TERM PERFORMANCE OF THIS IMPLANT DESIGN AND TO TEST THE HYPOTHESIS THAT IT WOULD SHOW A SUFFICIENTLY LOW RATE OF WEAR AND OSTEOLYSIS TO GUARANTEE A SURVIVORSHIP GREATER THAN 95 % AT MINIMUM 10 YEARS. THE ARTICLE REPORTS: BETWEEN 2000 AND 2002, A SINGLE SURGEON IMPLANTED A CEMENTED PFC SIGMA ROTATING-PLATFORM POSTERIOR-STABILIZED PROSTHESIS IN 160 CONSECUTIVE PATIENTS. IN TOTAL, AFTER MINIMUM 10 YEAR MINIMUM FOLLOW-UP, THERE WERE 5 PATIENTS THAT HAD UNDERGONE REVISION: ONE FOR INFECTION, ONE FOR ASEPTIC LOOSENING, TWO UNDERWENT PATELLA RESURFACING DUE TO INTRACTABLE PATELLA PAIN, AND THE LAST PATIENT UNDERWENT PATELLA RESURFACING DUE TO PATELLA DISLOCATION AND FRACTURE DUE TO TRAUMA A. THE PATELLA WAS NOT RESURFACED. CEMENT WAS USED ALTHOUGH THE MANUFACTURER WAS NOT DISCLOSED. THE PERIPROSTHETIC FRACTURES DUE TO TRAUMA ARE INCLUDED BECAUSE IT IS UNKNOWN IF THE TRAUMA WAS ATTRIBUTED TO THE DEVICE. ADDITIONALLY, THE ASEPTIC LOOSENING WILL NOT BE CODED FOR DUE TO INSUFFICIENT INFORMATION (CEMENT MANUFACTURER AND LOOSENING INTERFACE). DEPUY PRODUCTS INVOLVED: PFC RP PS. COMPLICATIONS: INFECTION (1), ASEPTIC LOOSENING (1), PAIN (2), PATELLA DISLOCATION (1), PATELLA FRACTURE (1), SURGICAL INTERVENTION (5).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122266 UNKNOWN KNEE TIBIAL INSERT KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention