BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS VEGA PS FEMORAL COMP.CEMENTED F4N R

    MDR report key: 7365469 · Received March 23, 2018

    Report

    Report Number
    9610612-2018-00125
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Report Date
    July 3, 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: NX029Z / AS VEGA PS FEMORAL COMP.CEMENTED F4N R, NX051Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T1, NN261Z / AS TIBIAL OBTURATOR D12MM, NX111 / VEGA PS GLIDING SURFACE T1/1+ 12MM, NX043 / PATELLA 3-PEGS P3. BRAND NAME: NX029Z. COMMON DEVICE NAME: AS VEGA PS FEMORAL COMP.CEMENTED F4N R. MODEL AND CATALOG # 52262250. EXPIRATION DATE: 07/31/2026. CONCOMITANT MEDICAL PRODUCTS: ADDED COMPONENTS. AGE OF DEVICE: 19 MONTHS. PMA/510K: K101281.

    Additional Manufacturer Narrative · 0

    NO PRODUCT AT HAND. THE PROVIDED X-RAY GIVES NO INFORMATION/INDICATIONS FOR THE MENTIONED FAILURE. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS, AND BEEN FOUND TO BE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. 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 FOR THE MENTIONED FAILURE. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE ROOT CAUSE OF THIS FAILURE IS MOST PROBABLY NOT PRODUCT RELATED. ACCORDING TO THE QUALITY STANDARD AND DHR FILES, A MATERIAL DEFECT OR PRODUCTION ERROR CAN BE EXCLUDED. UNFORTUNATELY DUE TO A LACK OF DATE/INFORMATION AND WITHOUT THE PRODUCT WE CAN NOT DETERMINE THE EXACT CAUSE OF THE FAILURE. ANY ACTION REGARDING CAPA WILL BE ADDRESSED WITH PRODUCT SAFETY CASE 17-19.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: USA. IT WAS REPORTED THAT THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2017, BUT THE SURGEON NOTICED THAT THE TIBIA HAD LOOSENED. REVISION SURGERY DATE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 0

    COMPONENTS IN USE LISTED AS CONCOMMITANT DEVICES ARE: NX029Z / AS VEGA PS FEMORAL COMP.CEMENTED F4N R, NX051Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T1, NN261Z / AS TIBIAL OBTURATOR D12MM, NX111 / VEGA PS GLIDING SURFACE T1/1+ 12MM, NX043 / PATELLA 3-PEGS P3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210316 AS VEGA PS FEMORAL COMP.CEMENTED F4N R FEMUR IMPLANTS VEGA SYSTEM JWH AESCULAP IMPLANT SYSTEMS NX029Z 52262250

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NN261Z / AS TIBIAL OBTURATOR D12MM| NX029Z / AS VEGA PS FEMORAL COMP.CEMENTED F4N R| NX043 / PATELLA 3-PEGS P3| NX051Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T1| NX111 / VEGA PS GLIDING SURFACE T1/1+ 12MM