BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS VEGA PS TIBIAL PLATEAU CEMENTED T4

    MDR report key: 7395705 · Received April 4, 2018

    Report

    Report Number
    9610612-2018-00147
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    January 27, 2017
    Report Date
    June 29, 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

    B5. COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX057Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T4, NN264Z / AS TIBIAL OBTURATOR D14MM, NX140 / VEGA PS GLIDING SURFACE T4/4+ 10MM, NN484 / COLUMBUS PATELLA 3-PEGS P4 36X10MM. D1. BRAND NAME: NX055Z. D2. COMMON DEVICE NAME: AS VEGA PS TIBIAL PLATEAU CEMENTED T4. D4. MODEL AND CATALOG # NX057Z. EXPIRATION DATE: 05/31/2025. F9. APPROXIMATE AGE OF DEVICE: 34 MONTHS. G5. 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 LOT 52127801 AND FOUND NOT TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION FOR ALL OTHER LOTS (52151713, 52129597, 52158619). SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THE BATCH 52129597. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THE 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 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 52127801): "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 MACHINE. ACCORDING TO THE TEST REPORTS, THE MEASURE IS ALWAYS WITHIN THE SPECIFICATION." UNFOURTUNATELY 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 17-19.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED: EVENT: COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX057Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T4, NN264Z / AS TIBIAL OBTURATOR D14MM, NX140 / VEGA PS GLIDING SURFACE T4/4+ 10MM, NN484 / COLUMBUS PATELLA 3-PEGS P4 36X10MM, BRAND NAME: NX055Z. COMMON DEVICE NAME: AS VEGA PS TIBIAL PLATEAU CEMENTED T4. MODEL AND CATALOG#: NX057Z. EXPIRATION DATE: 05/31/2025. 34 MONTHS. PMA/510K: K101281.

    Description of Event or Problem · 0

    (B)(6). RECEIVED VIA MEDWATCH (MW5075168): PROGRESSIVE LOOSENING TIBIA AND FEMUR, TOTAL KNEE LEFT SIDE, REVISED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. FILE WILL BE UPDATED WHEN INFORMATION IS RECEIVED. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2018-00147, 9610612-2018-00160.

    Description of Event or Problem · 0

    COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX057Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T4, NN264Z / AS TIBIAL OBTURATOR D14MM, NX140 / VEGA PS GLIDING SURFACE T4/4+ 10MM, NN484 / COLUMBUS PATELLA 3-PEGS P4 36X10MM.

    Description of Event or Problem · 0

    COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX057Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T4, NN264Z / AS TIBIAL OBTURATOR D14MM, NX140 / VEGA PS GLIDING SURFACE T4/4+ 10MM, NN484 / COLUMBUS PATELLA 3-PEGS P4 36X10MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238422 AS VEGA PS TIBIAL PLATEAU CEMENTED T4 FEMUR IMPLANTS VEGA SYSTEM JWH AESCULAP AG NX057Z 52151713

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NN264Z / AS TIBIAL OBTURATOR D14MM| NN264Z / AS TIBIAL OBTURATOR D14MM| NN484 / COLUMBUS PATELLA 3-PEGS P4 36X10MM| NN484 / COLUMBUS PATELLA 3-PEGS P4 36X10MM| NX057Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T4| NX057Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T4| NX140 / VEGA PS GLIDING SURFACE T4/4+ 10MM| NX140 / VEGA PS GLIDING SURFACE T4/4+ 10MM