BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE FEMORAL

    MDR report key: 9407632 · Received December 3, 2019

    Report

    Report Number
    1818910-2019-119794
    Event Type
    Injury
    Date Received
    December 3, 2019
    Date of Event
    November 8, 2013
    Report Date
    November 15, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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, 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 "THE EFFECTS OF FEMORAL COMPONENT DESIGN ON THE PATELLO-FEMORAL JOINT IN A PS TOTAL KNEE ARTHROPLASTY". LITERATURE ARTICLE "THE EFFECTS OF FEMORAL COMPONENT DESIGN ON THE PATELLO-FEMORAL JOINT IN A PS TOTAL KNEE ARTHROPLASTY" (2014) BY PIER FRANCESCO INDELLI ET AL. PUBLISHED BY ARCH ORTHOP TRAUMA SURG DOI 10.1007/S00402-013-1877-4 WAS REVIEWED. THE ARTICLE PURPOSE: TO INVESTIGATE WHETHER MODIFICATIONS TO THE FEMORAL DESIGN, COUPLED WITH THE NEW INSTRUMENTATION, HAD A POSITIVE IMPACT ON AVOIDING THE DEVELOPMENT OF ANTERIOR KNEE PAIN AND OTHER EXTENSOR MECHANISM COMPLICATIONS. THE ARTICLE REPORTS: BETWEEN OCTOBER 2009 AND APRIL 2010, 100 CONSECUTIVE PFC SIGMA PS POSTERIOR STABILIZED FIXED-BEARING KNEE PROSTHESES WERE PERFORMED ON 100 CONSECUTIVE PATIENTS. AT THE FINAL FOLLOW-UP, ALL PATIENTS WERE AVAILABLE FOR ANALYSIS. GOOD TO EXCELLENT CLINICAL RESULTS ACCORDING TO THE KNEE SOCIETY RATING SYSTEM WERE ACHIEVED IN 94 PERCENT OF THE KNEES. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. IN THE EARLY POSTOPERATIVE PERIOD, ONE PATIENT EXPERIENCED A PARTIAL RUPTURE OF THE QUADRICIPITAL TENDON DURING PHYSICAL THERAPY. 9 PATIENTS ALSO SUFFERED FROM PAIN ALTHOUGH, AGAIN, NO SURGICAL INTERVENTION WAS PERFORMED FOR THIS. 8 PATIENTS SUFFERED FROM CREPITATION AND TWO OF THESE REQUIRED SURGICAL REOPERATION TO REMOVE FIBROMATOUS TISSUE (CLUNK). ANOTHER PATIENT HAD A PATELLA FRACTURE 14 MONTHS POST-OPERATIVELY. THIS WAS TREATED CONSERVATIVELY, BUT THE PATIENT STILL REPORTED PAIN AT FINAL FOLLOW UP. ALL PATIENTS RECEIVED PFC SIGMA PS IMPLANTS. CEMENT USAGE WAS NOT MENTIONED WITHIN THE ARTICLE. THE PATELLA WAS ROUTINELY REPLACED. DEPUY PRODUCTS INVOLVED: PFC SIGMA PS. COMPLICATIONS: TENDON INJURY (1), PAIN (10), CREPITUS (6), PATELLA CLUNK SYNDROME (2), PATELLA FRACTURE (1), SURGICAL INTERVENTION (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194146 UNKNOWN KNEE FEMORAL KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention