BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS VEGA PS FEMORAL COMP.CEMENTED F4N L

    MDR report key: 7365462 · Received March 23, 2018

    Report

    Report Number
    9610612-2018-00129
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Report Date
    October 22, 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

    INVESTIGATION: NO PRODUCT AT HAND. THE PROVIDED X-RAY FIGURE GIVES NO INFORMATION/INDICATIONS OF THE MENTIONED FAILURE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS. THE DEVICE HISTORY FILES HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THESE BATCHES. CONCLUSION AND ROOT CAUSE: DUE TO THE CIRCUMSTANCE THAT WE DID NOT RECEIVE ANY DEVICES OR FURTHER INFORMATION, IT IS HARDLY POSSIBLE TO DETERMINE A CONCLUSION AND ROOT CAUSE OF THE MENTIONED FAILURE. WE ASSUME THAT THE ROOT CAUSE OF THE FAILURE IS MOST LIKELY NOT PRODUCT RELATED. RATIONAL: ACCORDING TO THE QUALITY STANDARD AND DHR FILES, A MATERIAL DEFECT OR PRODUCTION ERROR CAN BE EXCLUDED. UNFORTUNATELY, DUE TO A LACK OF INFORMATION AND WITHOUT THE PRODUCT WE CAN NOT DETERMINE THE EXACT CAUSE OF THE FAILURE. CORRECTIVE ACTION: PRODUCT SAFETY CASE 17-19 WAS OPENED. 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 DATE IS UNKNOWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED: COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX030Z / AS VEGA PS FEMORAL COMP.CEMENTED F4R, NX054Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T2+, NN261Z / AS TIBIAL OBTURATOR D12MM, NX121 / VEGA PS GLIDING SURFACE T2/2+ 12MM, NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM. BRAND NAME: NX030Z. COMMON DEVICE NAME: AS VEGA PS FEMORAL COMP.CEMENTED F4R. MODEL AND CATALOG # 51990540. EXPIRATION DATE: 12/01/2023. AGE OF DEVICE: 42 MONTHS PMA/510K: K101281.

    Description of Event or Problem · 1

    COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX030Z / AS VEGA PS FEMORAL COMP.CEMENTED F4R, NX054Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T2+, NN261Z / AS TIBIAL OBTURATOR D12MM, NX121 / VEGA PS GLIDING SURFACE T2/2+ 12MM, NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211184 AS VEGA PS FEMORAL COMP.CEMENTED F4N L FEMUR IMPLANTS VEGA SYSTEM JWH AESCULAP IMPLANT SYSTEMS NN483 52077966

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NN261Z / AS TIBIAL OBTURATOR D12MM| NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM| NX030Z / AS VEGA PS FEMORAL COMP.CEMENTED F4R| NX054Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T2+| NX121 / VEGA PS GLIDING SURFACE T2/2+ 12MM