BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN KNEE FEMORAL

    MDR report key: 12682757 · Received October 22, 2021

    Report

    Report Number
    1818910-2021-23316
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    August 12, 2020
    Report Date
    October 11, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 # ==> PC-(B)(4) INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE IMAGES WITHIN THE JOURNAL ARTICLE HAVE BEEN REVIEWED. X-RAYS WITHIN THE ARTICLE DID NOT SPECIFIED THE PRODUCT'S MANUFACTURER. OUT OF THE 100 CASES REVISED FOR ASEPTIC LOOSENING (AL) AND/OR RECURRENT PERIPROSTHETIC JOINT INFECTION (PJI), ONLY 5 CASES DEPICT DEPUY PRODUCTS. THE STUDY DID NOT SPECIFIED WHICH MANUFACTURER¿S PRODUCTS EXPERIENCED EITHER PJI OR AL. IT IS NOT POSSIBLE TO CONFIRM A DEPUY'S PRODUCT FAILURE AS WELL AS A RELATION BETWEEN THE ADVERSE EVENT AND THE REPORTED PRODUCT. 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 ==> THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Description of Event or Problem · 0

    ARTICLE ENTITLED, ¿HIGH RATES OF ASEPTIC LOOSENING AFTER REVISION TOTAL KNEE ARTHROPLASTY FOR PERIPROSTHETIC JOINT INFECTION", BY ARNE KIENZLE, MD, SANDY WALTER, PHILIPP VON ROTH, MD, MICHAEL FUCHS, MD, TOBIAS WINKLER, MD, AND MICHAEL MULLER, MD, PUBLISHED IN B JS OPEN ACCESS. 2020 AUG 12;5(3):E20.00026. DOI: 10.2106/JBJS.OA.20.00026. PMID: 32984749; PMCID: PMC7480970. THE AUTHORS RETROSPECTIVELY ANALYZED 100 PATIENTS WHO HAD UNDERGONE REVISION SURGERY TO ADDRESS PERIPROSTHETIC JOINT INFECTION, FOLLOWING UP ON THEM TO SEE THE INCIDENCE OF SUBSEQUENT ASEPTIC LOOSENING (AL) AND/OR RECURRENT PERIPROSTHETIC JOINT INFECTION (PJI). WITHIN THE 100 PATIENTS INITIALLY REVISED, 5 PATIENTS WERE INITIALLY REVISED WITH DEPUY TC3 STEMMED CONDYLAR CONSTRAINED KNEE (CCK) PROSTHESIS¿THE REMAINING 95 HAD COMPETITOR DEVICES. THE STUDY REPORTED THAT OVER THE 7.3 -YEAR FOLLOW-UP, 16 PATIENTS HAD RECURRENT PERIPROSTHETIC JOINT INFECTIONS. OVER THE SAME PERIOD, 22 PATIENTS EXPERIENCED ASEPTIC LOOSENING (SPECIFIC IMPLANTS AND INTERFACES INVOLVED WERE NOT PROVIDED). THE STUDY PROVIDED NO INFORMATION REGARDING WHICH MANUFACTURER¿S PRODUCTS EXPERIENCED EITHER PJI OR AL. THE STUDY PROVIDED NO INFORMATION WITH RESPECT TO TREATMENTS PROVIDED TO ADDRESS THE PJI OR AL. THE STUDY DID NOT PROVIDE DATA FOR EACH INDIVIDUAL PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1578851 UNKNOWN KNEE FEMORAL KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention