BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL TRAY

    MDR report key: 9168438 · Received October 8, 2019

    Report

    Report Number
    1818910-2019-108177
    Event Type
    Injury
    Date Received
    October 8, 2019
    Date of Event
    January 1, 2016
    Report Date
    September 27, 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 · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION DEPUY SYNTHESOF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. DEVICE HISTORY LOT : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. 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 RECEIVED ENTITLED "KNEE ARTHRODESIS WITH A LONG INTRAMEDULLARY NAIL AS LIMB SALVAGE FOR COMPLEX PERIPROSTHETIC INFECTIONS." LITERATURE ARTICLE "KNEE ARTHRODESIS WITH A LONG INTRAMEDULLARY NAIL AS LIMB SALVAGE FOR COMPLEX PERIPROSTHETIC INFECTIONS" (2016) BY NIMA RAZII, AMMAR M. I. ABBAS, RAHUL KAKAR, SANJEEV AGARWAL, AND RHIDIAN MORGAN-JONES PUBLISHED BY EUROPEAN JOURNAL OF ORTHOPAEDICS AND TRAUMATOLOGY DOI 10.1007/S00590-016-1827-2 WAS REVIEWED FOR MDR REPORTABILITY. THE ARTICLE PURPOSE: S TO EVALUATE THE OUTCOMES OF ARTHRODESIS WITH A LONG IM NAIL AS A SALVAGE PROCEDURE FOR COMPLEX PERIPROSTHETIC INFECTIONS OF PRIMARY OR REVISION TKA, OR INFECTED NON-UNION OF PREVIOUS FAILED ARTHRODESIS. THE ARTICLE REPORTS: TWELVE CONSECUTIVE CASES OF KNEE ARTHRODESIS WITH A COMPETITOR'S LONG IM NAIL PERFORMED AT BETWEEN JUNE 2003 AND MARCH 2014 WERE REVIEWED RETROSPECTIVELY. THE STUDY GROUP COMPRISED 9 MALES AND 3 FEMALES, WITH A MEAN AGE OF 67 YEARS (RANGE 35¿88 YEARS). THE INDICATIONS COMPRISED INFECTED REVISION TKA (FIVE PATIENTS), FAILED PREVIOUS ARTHRODESIS (FOUR PATIENTS), AND INFECTED PRIMARY TKA (THREE PATIENTS). ONLY ONE OF THESE PATIENTS ((B)(6)-YEAR-OLD MALE) HAD A DEPUY KNEE IMPLANT. THIS PATIENT (CASE 11) PRESENTED WITH AN EXTENSOR MECHANISM FAILURE SECONDARY TO DEEP INFECTION (VRE FAECALIS). IT IS NOT INDICATED HOW LONG POST-OPERATION THIS INFECTION OCCURRED. FOLLOWING SURGICAL DEBRIDEMENT AND STABILIZATION WITH THE COMPETITOR'S IM NAIL, THE PATIENT HAD NO REPORTED COMPLICATIONS AT TIME OF MOST RECENT FOLLOW UP. THE ARTICLE DOES NOT REPORT WHETHER CEMENT WAS USED OR WHETHER PATELLA RESURFACING WAS CONDUCTED. DEPUY PRODUCTS INVOLVED: S-ROM NOILES PROSTHESIS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963662 UNKNOWN KNEE TIBIAL TRAY KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R