BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS VEGA PS TIBIAL PLATEAU CEMENTED T3+

    MDR report key: 7394119 · Received April 3, 2018

    Report

    Report Number
    9610612-2018-00170
    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: COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX056Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T3+ 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 TIBIAL PLATEAU CEMENTED T3+. MODEL AND CATALOG # NX056Z. EXPIRATION DATE:04/01/2024. CONCOMITANT MEDICAL PRODUCTS. ADDED COMPONENTS. APPROXIMATE AGE OF DEVICE: 46 MONTHS. PMA/510K# K101281.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO PRODUCT IS AT HAND. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE LOT NUMBER 52034818, AND FOUND NOT TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. ALL OTHER LOT NUMBERS (52129597, 52077135, 52134791) WERE FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THE BATCH 52129597 AND 52134791. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM OTHER BATCHES. CONCLUSION AND ROOT CAUSE: 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. RATIONAL: ACCORDING TO THE QUALITY STANDARD AND DHR FILES, A MATERIAL DEFECT OR PRODUCTION ERROR CAN BE EXCLUDED. THERE IS NO CORRELATION BETWEEN THE DEVIATING COMPONENT AND THE FAILURE. ADDITIONALLY, ACCORDING TO THE QUALITY COORDINATOR IN RELATION TO THE DEVIATING COMPONENT MEASURE 19 +/- 0.1MM (LOT 52034818): "WE CAN ASSUME THAT THIS IS A TYPOGRAPHICAL ERROR. THE PARTS ARE MADE BY ROBOTIC HANDLING OVERNIGHT, SO ONLY A PART IS TESTED. SUBSEQUENTLY, A SAMPLE OF 4 PARTS IS TESTED ON THE MEASURING MACHING. ACCORDING TO THE TEST REPORTS, THE MEASURE IS ALWAYS WITHIN THE SPECIFICATION." UNFORTUNATELY DUE TO A LACK OF DATA AND WITHOUT THE PRODUCT, WE CAN NOT DETERMINE THE EXACT CAUSE. CORRECTIVE ACTION: ANY ACTION REGARDING CAPA WILL BE ADDRESSED WITH PRODUCT SAFETY CASE (B)(4).

    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: 9610612-2018-00153.

    Description of Event or Problem · 0

    COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX056Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T3+, 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
    237206 AS VEGA PS TIBIAL PLATEAU CEMENTED T3+ FEMUR IMPLANTS VEGA SYSTEM JWH AESCULAP AG NX056Z 52034818

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NN264Z / AS TIBIAL OBTURATOR D14MM| NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM| NX056Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T3+| NX131 / VEGA PS GLIDING SURFACE T3/3+ 12MM