BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL INSERT

    MDR report key: 9545399 · Received January 3, 2020

    Report

    Report Number
    1818910-2020-00295
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    November 15, 2018
    Report Date
    December 17, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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

    THE LITERATURE ARTICLE ENTITLED, "MEDIAL FEMORAL EPICONDYLE UPSLIDING OSTEOTOMY WITH POSTERIOR STABILIZED ARTHROPLASTY PROVIDED GOOD CLINICAL OUTCOMES SUCH AS CONSTRAINED ARTHROPLASTY IN PRIMARY TOTAL KNEE ARTHROPLASTY WITH SEVERE VALGUS DEFORMITY" WRITTEN BY PING MOU, YI ZENG, FUXING PEI, ZONGKE ZHOU, BIN SHEN, PENGDE KANG AND JING YANG PUBLISHED BY KNEE SURGERY, SPORTS TRAUMATOLOGY, ARTHROSCOPY (2019) 27: 2266-2275 PUBLISHED ONLINE 15 NOVEMBER 2018 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO COMPARE TO EFFECTIVENESS OF THE MODIFIED TECHNIQUE OF FEMORAL EPICONDYLE UPSLIDING OSTEOTOMY VERSUS PS ARTHROPLASTY WITH CONSTRAINED ARTHROPLASTY DURING PRIMARY TOTAL KNEE ARTHROPLASTY. DATA WAS COMPILED FROM TWO GROUPS (GROUP A AND GROUP B). GROUP A CONSISTED OF 26 PATIENTS (28 KNEES) WITH DEPUY SIGMA PFC AND NON-DEPUY KNEE IMPLANTS, AND GROUP B CONSISTED OF 28 PATIENTS (28 KNEES) WITH ALL DEPUY SIGMA TCP III KNEE IMPLANTS. ARTICLE DOES NOT MENTION PATELLA RESURFACING AND CEMENT MANUFACTURER IS NOT IDENTIFIED. THE ARTICLE DOES NOT IDENTIFY WHICH SPECIFIC EVENTS ARE RELATED TO WHICH SPECIFIC PRODUCTS FOR GROUP A. ADVERSE EVENTS IN GROUP A (SIGMA PFC OR NON-DEPUY): ONE POSTOPERATIVE PERIPROSTHETIC FEMORAL FRACTURE "DUE TO AN UNEXPECTED IN-HOSPITAL FALL" (TREATED WITH CORTICAL BONE PLATE ALLOGRAFTS MEDIALLY AND A CONDYLAR PLATE WITH INTERNAL FIXATION LATERALLY. ADVERSE EVENTS IN GROUP B (SIGMA TCP III): ONE SUPERFICIAL WOUND BREAKDOWN (TREATED BY DEBRIDEMENT AND EXTENDED ANTIBIOTICS), PATELLAR FRACTURE "DUE TO AN ACCIDENTAL FALL" (TREATED BY EMERGENCY SURGERY WITH OPEN REDUCTION AND INTERNAL FIXATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6161 UNKNOWN KNEE TIBIAL INSERT KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention