BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL TRAY

    MDR report key: 9293836 · Received November 7, 2019

    Report

    Report Number
    1818910-2019-114942
    Event Type
    Injury
    Date Received
    November 7, 2019
    Date of Event
    November 11, 2004
    Report Date
    October 21, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. 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

    LITERATURE ARTICLE WAS RECEIVED ENTITLED "RECONSTRUCTION OF THE TIBIAL DIAPHYSIS WITH TRANSFER OF THE TIBIAL HEAD ONTO THE PROXIMAL FIBULA". LITERATURE ARTICLE "RECONSTRUCTION OF THE TIBIAL DIAPHYSIS WITH TRANSFER OF THE TIBIAL HEAD ONTO THE PROXIMAL FIBULA" (2004) BY A. MARX , J. PFÖRTNER, G. SAXLER PUBLISHED BY TRAUMA SURGEON DOI 10.1007/S00113-004-0875-Y WAS REVIEWED. THE ARTICLE PURPOSE: TO PRESENT A CASE REPORT REGARDING RECONSTRUCTION OF THE TIBIAL DIAPHYSIS WITH TRANSFER OF THE TIBIAL HEAD ONTO THE PROXIMAL FIBULA. THE ARTICLE REPORTS: A 69-YEAR-OLD PATIENT PRESENTED HERSELF WITH REFERRAL DIAGNOSIS OF "RIGHT KNEE OSTEOARTHRITIS". THE PATIENT REPORTED THAT A LOWER LEG BONE INFECTION HAD OCCURRED IN CHILDHOOD. THERE WAS NO TRAUMA WITH BONY INJURY. DUE TO THE LOWER LEG OSTEOMYELITIS, A HIGH-TIBIAL SURGERY WAS CARRIED OUT AT THE AGE OF 6 YEARS. DETAILED INFORMATION ON THE TYPE AND SCOPE OF THE INDEX INTERVENTION WAS NOT KNOWN. THE REQUIRED IMPLANT SIZE ON THE TIBIAL SIDE OF THE DYSPLASTIC VENTROMEDIAL CORTEX WAS GR. 1 (TYPE LCS, JOHNSON & JOHNSON, DEPUY, WARSAW/IN, USA). HOWEVER, IMPLANTATION OF THE TIBIAL COMPONENT RESULTED IN A FRACTURE OF THE VENTRAL CORTICAL BONE, WHICH WAS OSTEOSYNTHETICALLY TREATED WITH WIRE CERCLAGE. WIRE MANUFACTURER WAS NOT DISCLOSED. PATELLA RESURFACING AND CEMENT USAGE/MANUFACTURER WAS NOT DISCLOSED. OUTSIDE OF THE INTRA-OP FRACTURE, NO OTHER COMPLICATIONS OCCURRED. IN THE LONG-TERM FOLLOW-UP IN THIS CASE, NO SIGNIFICANT LOSS OF FUNCTION OF THE KNEE JOINT OCCURRED. DEPUY PRODUCTS INVOLVED: LCS KNEE SYSTEM. COMPLICATIONS: INSTA-OP FRACTURE (1), SURGICAL INTERVENTION (1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088326 UNKNOWN KNEE TIBIAL TRAY KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention