BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS VEGA PS FEMORAL COMP.CEMENTED F5N L

    MDR report key: 7365475 · Received March 23, 2018

    Report

    Report Number
    9610612-2018-00124
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Report Date
    June 14, 2018
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    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: DESCRIBE EVENT OR PROBLEM: COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX011Z / AS VEGA PS FEMORAL COMP. CEMENTED F5N L. NX053Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T2. NN261Z / AS TIBIAL OBTURATOR D12MM. NX120 / VEGA PS GLIDING SURFACE T2/2+ 10MM. NX042 / PATELLA 3-PEGS P2. BRAND NAME: NX011Z. COMMON DEVICE NAME: AS VEGA PS FEMORAL COMP. CEMENTED F5N L. MODEL AND CATALOG # 52244726. EXPIRATION DATE: 06/30/2026. CONCOMITANT MEDICAL PRODUCTS. ADDED COMPONENTS. APPROX AGE OF DEVICE: 21 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 ALL LOT NUMBERS AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THE 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 AND PRODUCTION ERROR CAN BE EXCLUDED. UNFORTUNATELY DUE TO A LACK OF DATA AND WITHOUT THE PRODUCT WE CAN NOT DETERMINE THE EXACT CAUSE. CORRECTIVE ACTION: PRODUCT SAFETY CASE (B)(4). ANY ACTION REGARDING CAPA WILL BE ADDRESSED WITH THIS CASE.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: USA. IT WAS REPORTED THAT THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2016, BUT THE SURGEON NOTICED THAT THE TIBIA HAD LOOSENED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018.

    Description of Event or Problem · 0

    COMPONENTS IN USE LISTED AS CONCOMMITANT DEVICES ARE: NX011Z / AS VEGA PS FEMORAL COMP. CEMENTED F5N L. NX053Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T2. NN261Z / AS TIBIAL OBTURATOR D12MM. NX120 / VEGA PS GLIDING SURFACE T2/2+ 10MM. NX042 / PATELLA 3-PEGS P2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210493 AS VEGA PS FEMORAL COMP.CEMENTED F5N L FEMUR IMPLANTS VEGA SYSTEM JWH AESCULAP IMPLANT SYSTEMS NX011Z 52244726

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NN261Z / AS TIBIAL OBTURATOR D12MM| NX011Z / AS VEGA PS FEMORAL COMP.CEMENTED F5N L| NX042 / PATELLA 3-PEGS P2| NX053Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T2| NX120 / VEGA PS GLIDING SURFACE T2/2+ 10MM