BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE FEMORAL ADAPTOR BOLT

    MDR report key: 9408004 · Received December 4, 2019

    Report

    Report Number
    1818910-2019-119931
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    August 25, 2011
    Report Date
    November 13, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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. 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 "FRACTURE AT THE STEM¿CONDYLAR JUNCTION OF A MODULAR FEMORAL PROSTHESIS IN A VARUS¿VALGUS CONSTRAINED TOTAL KNEE ARTHROPLASTY" BY D. D. NIKOLOPOULOS, I. G. POLYZOIS, E. A. MAGNISSALIS, P. F. BERNARD, AND I. V. MICHOS PUBLISHED BY KNEE SURG SPORTS TRAUMATOL ARTHROSC DOI 10.1007/S00167-011-1652-4 WAS REVIEWED. THE ARTICLE PURPOSE: TO PRESENT THE CASE OF A FRACTURE OF A MODULAR FEMORAL STEM TO INVESTIGATE THE REASONS FOR FAILURE. THE ARTICLE REPORTS: AFTER A PRIMARY TKA WAS PERFORMED NINE YEARS PRIOR, A (B)(6) WOMAN RECEIVED A SECONDARY REVISION SURGERY WITH A DEPUY PFC SIGMA TCIII IMPLANT. THIS PROCEDURE WENT WITHOUT COMPLICATIONS AND THE POST-OPERATIVE PERIOD WAS UNEVENTFUL. TWO YEARS LATER SHE PRESENTED WITH KNEE PAIN AND INSTABILITY. ANOTHER REVISION SURGERY WAS PLANNED WHERE A COMPETITOR IMPLANT WAS USED. DURING THIS SURGERY, THE FEMORAL PROSTHESIS WAS FOUND DAMAGED AT THE SITE OF THE MODULAR INTRAMEDULLARY STEM AND SCREW JUNCTION WITH THE FEMORAL ARTICULATING ELEMENT. AT FINAL FOLLOW UP, THE PATIENT WAS SYMPTOM-FREE AND COULD AMBULATE INDEPENDENTLY. CEMENT WAS USED ALTHOUGH THE MANUFACTURER WAS NOT DISCLOSED. PATELLA RESURFACING WAS LIKEWISE NOT MENTIONED WITHIN THE ARTICLE. DEPUY PRODUCTS INVOLVED: P.F.C. SIGMA TC3. COMPLICATIONS: IMPLANT FRACTURE (1), SURGICAL INTERVENTION (1), MEDICAL DEVICE IMPLANT REMOVAL (1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203841 UNKNOWN KNEE FEMORAL ADAPTOR BOLT UNKNOWN KNEE IMPLANT JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention