BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK REAMER

    MDR report key: 11551830 · Received March 23, 2021

    Report

    Report Number
    1818910-2021-05567
    Event Type
    Injury
    Date Received
    March 23, 2021
    Report Date
    February 25, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE DEVICE TO EXAMINE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: PRODUCT/LOT INFORMATION IS NOT AVAILABLE CORRECTED: G1.

    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. 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

    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.

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE "INTRAOPERATIVE FEMORAL CONDYLE FRACTURE IN PRIMARY TOTAL KNEE ARTHROPLASTY - A CASE-CONTROL STUDY IN ASIAN POPULATION" WRITTEN BY YIK-FUNG MAK, QUNN-JID LEE, WAI-YEE ESTHER CHANG, AND YIU-CHUNG WONG PUBLISHED BY KNEE SURGERY AND RELATED RESEARCH (2020) WAS REVIEWED. HTTPS://DOI.ORG/10.1186/S43019-020-00043-6. THE ARTICLE'S PURPOSE WAS TO IDENTIFY THE INCIDENCE, RISK FACTORS, LOCATION AND OUTCOME OF INTRAOPERATIVE FEMORAL CONDYLE FRACTURES. DATA WAS COMPILED FROM 2682 PRIMARY TKAS PERFORMED BETWEEN 2011 AND 2017 IN A SINGLE CENTER. OF THIS DATA SET, 23 FEMORAL CONDYLE FRACTURES WERE IDENTIFIED AND ANALYZED. TABLE 1 PROVIDES THE DETAILS OF THE 23 CASES. IT IS NOTED THAT ONLY PATIENT B AND PATIENT T HAVE DEPUY IMPLANTS. THIS COMPLAINT CAPTURES THOSE TWO CASES. ARTICLE REPORTS PATELLAR RESURFACING WAS PERFORMED PER SURGEON'S DISCRETION, AND CEMENT MANUFACTURER WAS NOT IDENTIFIED. THE ARTICLE REPORTS ALL PATIENTS ACHIEVED BONE UNION AND A GOOD FUNCTIONAL OUTCOME WHETHER MANAGEMENT WAS CONSERVATIVE WITH PARTIAL WEIGHT BEARING FOR 1-2 MONTHS OR UNDERWENT IMMEDIATE FIXATION WITH CANNULATED SCREWS. FIGURE 2 PROVIDES RADIOGRAPHIC IMAGING OF TWO PATIENTS WHO SUFFERED FROM INTRAOPERATIVE FEMORAL FRACTURES BUT DOES IDENTIFY WHICH PATIENTS FROM TABLE ARE UTILIZED IN THE FIGURE. THE OTHER PHOTOGRAPHIC IMAGES IN THE ARTICLE ARE OF NON-DEPUY PRODUCTS. ADVERSE EVENTS: PATIENT B IS A (B)(6) YEARS OLD FEMALE WITH 26.4 BMI WHO RECEIVED A RIGHT PFC PRIMARY KNEE CONSTRUCT AND EXPERIENCED AN INTRAOPERATIVE MEDIAL CONDYLE FRACTURE THAT WAS DISCOVERED POSTOPERATIVELY AND MANAGED CONSERVATIVELY WITH PARTIAL WEIGHT BEARING 1-2 MONTHS. PATIENT T IS A (B)(6) YEARS OLD FEMALE WITH 23.8 BMI WHO RECEIVED A LEFT ATTUNE PRIMARY KNEE CONSTRUCT AND EXPERIENCED AN INTRAOPERATIVE LATERAL CONDYLE FRACTURE THAT OCCURRED DURING PACTION OF IMPLANT AND MANAGED BY IMMEDIATE SCREW FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452378 UNK REAMER INSTRUMENT REAMER HTO DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention