BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE FEMORAL

    MDR report key: 9298019 · Received November 8, 2019

    Report

    Report Number
    1818910-2019-115351
    Event Type
    Injury
    Date Received
    November 8, 2019
    Date of Event
    May 1, 2003
    Report Date
    October 22, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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. H10 ADDITIONAL NARRATIVE: 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 RECEIVED TITLED, " LONG-TERM CLINICAL OUTCOMES AND SURVIVORSHIP OF PRESS-FIT CONDYLAR SIGMA FIXED-BEARING AND MOBILE-BEARING TOTAL KNEE PROSTHESES IN THE SAME PATIENTS" LITERATURE ARTICLE "LONG-TERM CLINICAL OUTCOMES AND SURVIVORSHIP OF PRESS-FIT CONDYLAR SIGMA FIXED-BEARING AND MOBILE-BEARING TOTAL KNEE PROSTHESES IN THE SAME PATIENTS" (2014) BY YOUNG-HOO KIM, MD, JANG-WON PARK, MD, JUN-SHIK KIM, MD, SOURABH S. KULKARNI, MD, AND YOON-HONG KIM, MD PUBLISHED BY THE JOURNAL OF BONE AND JOINT SURGERY HTTP://DX.DOI.ORG/10.2106/JBJS.M.01130 WAS REVIEWED. THE ARTICLE PURPOSE: TO COMPARE THE FUNCTIONAL SCORES, RADIOGRAPHIC RESULTS, PREVALENCE OF OSTEOLYSIS, AND OVERALL REVISION RATES BETWEEN THE MOBILE AND FIXED-BEARING PROSTHESES AT A MEAN OF 12.1 YEARS FOLLOW-UP. THE ARTICLE REPORTS: FROM JUNE 2000 TO MAY 2003, 484 CONSECUTIVE PATIENTS (968 KNEES) WITH BILATERAL KNEE OSTEOARTHRITIS UNDERWENT SIMULTANEOUS TOTAL KNEE ARTHROPLASTIES, WITH ONE SIDE TREATED IMMEDIATELY AFTER THE OTHER. THE KNEE SOCIETY KNEE SCORES DID NOT DIFFER SIGNIFICANTLY BETWEEN THE GROUPS PREOPERATIVELY OR AT THE FINAL FOLLOW-UP. PAIN WAS REPORTED IN EACH GROUP, BUT THERE WAS NO PAIN REPORTED WORSE THAN MODERATE PAIN (ONLY S2 ACCORDING TO SCP 1404 - SO NOT REPORTABLE). SIX KNEES (1.4%) IN THE MOBILE-BEARING GROUP AND EIGHT KNEES (1.8%) IN THE FIXED-BEARING GROUP WERE REVISED FOR ASEPTIC LOOSENING. TWO KNEES (0.5%) IN EACH GROUP WERE REVISED FOR DEEP INFECTION. ONE KNEE (0.2%) IN THE FIXEDBEARING GROUP WAS REVISED FOR RECURRENT PATELLAR DISLOCATION. PATELLA WERE ROUTINELY RESURFACED IN ALL IMPLANTS. CEMENT WAS USED IN ALL IMPLANTS ALTHOUGH THE MANUFACTURER WAS NOT DISCLOSED. DEPUY PRODUCTS INVOLVED: PFC SIGMA FB AND PFC SIGMA MB. COMPLICATIONS IN PFC SIGMA FB: ASEPTIC LOOSENING (8), INFECTION (2), PATELLA DISLOCATION (1), SURGICAL INTERVENTION (11). COMPLICATIONS IN PFC SIGMA MB: ASEPTIC LOOSENING (6), INFECTION (2), SURGICAL INTERVENTION (8). LOOSENING WILL NOT BE CODED FOR DUE TO INSUFFICIENT INFORMATION. THE FIRST FOUR PRODUCTS ARE FOR THE PFC SIGMA FB IMPLANT COMPONENTS. THE FOLLOWING FOUR PRODUCTS ARE FOR THE PFC SIGMA MB IMPLANT COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095984 UNKNOWN KNEE FEMORAL KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention