BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS VEGA PS FEMORAL COMP.CEMENTED F6N R

    MDR report key: 7394116 · Received April 3, 2018

    Report

    Report Number
    9610612-2018-00153
    Event Type
    Malfunction
    Date Received
    April 3, 2018
    Date of Event
    September 6, 2017
    Report Date
    June 25, 2018
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    PMA / PMN Number
    K101281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED: EVENT. COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX033Z / AS VEGA PS FEMORAL COMP. CEMENTED F6N R, NN264Z / AS TIBIAL OBTURATOR D14MM, NX131 / VEGA PS GLIDING SURFACE T3/3+ 12MM, NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM. BRAND NAME: AS VEGA PS FEMORAL COMP. CEMENTED F6N R. MODEL AND CATALOG#: NX033Z. EXPIRATION DATE:08/01/2023. CONCOMITANT MEDICAL PRODUCTS: 4 YEARS. PMA/510K: K101281.

    Additional Manufacturer Narrative · 0

    NO PRODUCT IS AT HAND. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL THE LOT NUMBERS, AND FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM BATCH 52129597 AND 52134791. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THE OTHER BATCHES. NO PRODUCT AVAILABLE, AND THEREFORE A COMPLETE ANALYSIS IS NOT POSSIBLE, BUT BASED ON THE INFORMATION AVAILABLE, IT APPEARS THE ROOT CAUSE OF THE FAILURE IS NOT PRODUCT RELATED. THERE IS THE POSSIBILITY THAT THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE OR PATIENT RELATED. ACCORDING TO THE QUALITY STANDARD AND DHR FILES, A MATERIAL DEFECT OR PRODUCTION ERROR CAN BE EXCLUDED. UNFORTUNATELY DUE TO A LACK OF DATA AND WITHOUT THE PRODUCT, WE CAN NOT DETERMINE THE EXACT CAUSE. ANY ACTION REGARDING CAPA WILL BE ADDRESSED WITH PRODUCT SAFETY CASE (B)(6).

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: USA. RECEIVED VIA MEDWATCH (MW5075188): EVENT DESCRIPTION PER MW REPORT: FAILED TOTAL KNEE CEMENT LOOSENING GLOBAL FAILURE TIBIA FIRST REVISED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. FILE WILL BE UPDATED WHEN INFORMATION IS RECEIVED. MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2018-00170.

    Description of Event or Problem · 0

    COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX033Z / AS VEGA PS FEMORAL COMP. CEMENTED F6N R, NN264Z / AS TIBIAL OBTURATOR D14MM, NX131 / VEGA PS GLIDING SURFACE T3/3+ 12MM, NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236418 AS VEGA PS FEMORAL COMP.CEMENTED F6N R FEMUR IMPLANTS VEGA SYSTEM JWH AESCULAP AG NX033Z 51973302

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NN264Z / AS TIBIAL OBTURATOR D14MM| NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM| NX033Z / AS VEGA PS FEMORAL COMP.CEMENTED F6N R| NX131 / VEGA PS GLIDING SURFACE T3/3+ 12MM