BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS VEGA PS FEMORAL COMP.CEMENTED F4N L

    MDR report key: 7365464 · Received March 23, 2018

    Report

    Report Number
    9610612-2018-00132
    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: COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX009Z / AS VEGA PS FEMORAL COMP.CEMENTED F4N L. NX053Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T2. NN261Z / AS TIBIAL OBTURATOR D12MM. NX121 / VEGA PS GLIDING SURFACE T2/2+ 12MM. NN482 / COLUMBUS PATELLA 3-PEGS P2 30X8MM. BRAND NAME: NX009Z. COMMON DEVICE NAME: AS VEGA PS FEMORAL COMP.CEMENTED F4N L. MODEL AND CATALOG # 52137600. EXPIRATION DATE: 04/30/2025. CONCOMITANT MEDICAL PRODUCTS: ADDED COMPONENTS. AGE OF DEVICE: 34 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. SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM BATCH 52057722, 52137600, 52128834, AND 52012337. 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 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 17-19. ANY ACTION REGARDING CAPA WILL BE ADDRESSED WITH THIS CASE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED: COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX009Z / AS VEGA PS FEMORAL COMP.CEMENTED F4N L; NX053Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T2; NN261Z / AS TIBIAL OBTURATOR D12MM; NX121 / VEGA PS GLIDING SURFACE T2/2+ 12MM; NN482 / COLUMBUS PATELLA 3-PEGS P2 30X8MM. BRAND NAME: NX009Z. COMMON DEVICE NAME: AS VEGA PS FEMORAL COMP.CEMENTED F4N L. MODEL AND CATALOG # 52137600. EXPIRATION DATE: 04/30/2025. APPROXIMATE AGE OF DEVICE: 34 MONTHS. PMA/510K: K101281.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: USA. IT WAS REPORTED THAT THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2015, BUT THE SURGEON NOTICED THAT THE TIBIA HAD LOOSENED. REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2018.

    Description of Event or Problem · 0

    COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX009Z / AS VEGA PS FEMORAL COMP.CEMENTED F4N L. NX053Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T2. NN261Z / AS TIBIAL OBTURATOR D12MM. NX121 / VEGA PS GLIDING SURFACE T2/2+ 12MM. NN482 / COLUMBUS PATELLA 3-PEGS P2 30X8MM.

    Description of Event or Problem · 0

    COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX009Z / AS VEGA PS FEMORAL COMP.CEMENTED F4N L; NX053Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T2; NN261Z / AS TIBIAL OBTURATOR D12MM; NX121 / VEGA PS GLIDING SURFACE T2/2+ 12MM; NN482 / COLUMBUS PATELLA 3-PEGS P2 30X8MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210298 AS VEGA PS FEMORAL COMP.CEMENTED F4N L FEMUR IMPLANTS VEGA SYSTEM JWH AESCULAP IMPLANT SYSTEMS NX009Z 52137600

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NN261Z / AS TIBIAL OBTURATOR D12MM| NN261Z / AS TIBIAL OBTURATOR D12MM| NN482 / COLUMBUS PATELLA 3-PEGS P2 30X8MM| NN482 / COLUMBUS PATELLA 3-PEGS P2 30X8MM| NX009Z / AS VEGA PS FEMORAL COMP.CEMENTED F4N L| NX009Z / AS VEGA PS FEMORAL COMP.CEMENTED F4N L| NX053Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T2| NX053Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T2| NX121 / VEGA PS GLIDING SURFACE T2/2+ 12MM| NX121 / VEGA PS GLIDING SURFACE T2/2+ 12MM