BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE PATELLA

    MDR report key: 9212641 · Received October 20, 2019

    Report

    Report Number
    1818910-2019-110843
    Event Type
    Injury
    Date Received
    October 20, 2019
    Date of Event
    August 27, 2014
    Report Date
    October 11, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). 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.

    Additional Manufacturer Narrative · 1

    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. 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 WAS RECEIVED ENTITLED "PATELLAR CLUNK IN TOTAL KNEE ARTHROPLASTY USING MODIFIED SIGMA POSTERIOR STABILIZED FEMORAL COMPONENT". LITERATURE ARTICLE "PATELLAR CLUNK IN TOTAL KNEE ARTHROPLASTY USING MODIFIED SIGMA POSTERIOR STABILIZED FEMORAL COMPONENT" (2014) BY K.T. RAJSHEKHAR M.S, M.N. KUMAR M.S, P. VENUGOPAL M.S, AND THOMAS CHANDY PUBLISHED BY JOURNAL OF CLINICAL ORTHOPAEDICS AND TRAUMA HTTP://DX.DOI.ORG/10.1016/J.JCOT.2014.07.013 WAS REVIEWED. THE ARTICLE PURPOSE: TO ASSESS THE EFFECT OF MODIFICATION IN THE DESIGN OF PROSTHESIS ON THE INCIDENCE OF PATELLAR CLUNK. THE ARTICLE REPORTS: BETWEEN AUGUST 2012 AND AUGUST 2013, 133 TOTAL KNEE REPLACEMENTS WERE DONE IN 88 PATIENTS. PATELLA WAS RESURFACED IN ALL THE PATIENTS. CEMENT WAS USED IN ALL THE PATIENTS ALTHOUGH THE MANUFACTURER WAS NOT DISCLOSED. 3 PATIENTS WERE NOT ABLE TO ATTEND THE HOSPITAL FOR FOLLOW-UP. THE CLINICAL AND RADIOLOGICAL EVALUATIONS WERE DONE IN THE REMAINING 85 PATIENTS AT INTERVALS OF 1 MONTH, 3 MONTH, 6 MONTH, 1 YEAR AND EVERY 6 MONTH THEREAFTER. PATELLAR CLUNK WAS IDENTIFIED IN 3 PATIENTS. IN 3 PATIENTS (2%) THERE WAS CREPITUS WITHOUT ANY CLUNK. ONE PATIENT WHO HAD PATELLAR CLUNK RECEIVED ANTI-INFLAMMATORY INTERVENTION AND THE CLUNK SPONTANEOUSLY REDUCED. ANOTHER PATIENT WAS ADVISED TO SEEK SURGICAL INTERVENTION, BUT THE AUTHORS DID NOT REPORT THAT THE PATIENT ACTUALLY RECEIVED ANY SURGICAL INTERVENTION. DEPUY PRODUCTS INVOLVED: DEPUY PFC FIXED-BEARING. COMPLICATIONS: PATELLAR CLUNK (3), CREPITUS (3), SURGICAL INTERVENTION (1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006858 UNKNOWN KNEE PATELLA KNEE PATELLA JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention