BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS TIBIA OFFSET STEM D15X92MM CEMENTED

    MDR report key: 7395691 · Received April 4, 2018

    Report

    Report Number
    9610612-2018-00152
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    June 5, 2017
    Report Date
    June 25, 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

    ADDITIONAL INFORMATION PROVIDED: EVENT: COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NR195Z / AS TIBIA OFFSET STEM D15X92MM CEMENTED, NR072Z / AS COLUMBUS REV F TIB. OFFSET CEMENT. T1+, NR002Z / AS COLUMBUS REV F FEMUR CEMENTED F2L, NR292Z / AS FEMUR EXTENS. STEM 6° D15X77 CEMENTED, NR113M / COLUMBUS REV F MC GLID. SURF. T1/1+ 16MM, NR400Z / AS NUT F/FEMUR EXTENS. STEM ALL SZ. NEUTR., NR246Z / AS COLUMBUS TIB. HEMI-SP. T1/1+ 15MM RL/LM, NR462Z / AS COLUMBUS REV FEM.S PACER DIST. F2 5MM, NR462Z / AS COLUMBUS REV FEM. SPACER DIST. F2 5MM. BRAND NAME: AS TIBIA OFFSET STEM D15X92MM CEMENTED. COMMON DEVICE NAME. MODEL AND CATALOG#: NR195Z. EXPIRATION DATE: 03/31/2025. CONCOMITANT MEDICAL PRODUCTS: ADDED COMPONENTS. 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 THE LOT NUMBERS, AND FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THESE 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 OR 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: NO CAPA IS NECESSARY.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: USA. RECEIVED VIA MEDWATCH (MW5075206): INFORMATION FROM MEDWATCH: COLUMBUS REVISION STEM REVISED / LOOSENING TOTAL KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. FILE WILL BE UPDATED WHEN INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NR195Z / AS TIBIA OFFSET STEM D15X92MM CEMENTED, NR072Z / AS COLUMBUS REV F TIB. OFFSET CEMENT. T1+, NR002Z / AS COLUMBUS REV F FEMUR CEMENTED F2L, NR292Z / AS FEMUR EXTENS. STEM 6° D15X77 CEMENTED, NR113M / COLUMBUS REV F MC GLID. SURF. T1/1+ 16MM, NR400Z / AS NUT F/FEMUR EXTENS. STEM ALL SZ.NEUTR., NR246Z / AS COLUMBUS TIB. HEMI-SP. T1/1+ 15MM RL/LM, NR462Z / AS COLUMBUS REV FEM. SPACER DIST. F2 5MM, NR462Z / AS COLUMBUS REV FEM. SPACER DIST. F2 5MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240244 AS TIBIA OFFSET STEM D15X92MM CEMENTED FEMUR IMPLANTS VEGA SYSTEM JWH AESCULAP AG NR195Z 52133197

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NR002Z / AS COLUMBUS REV F FEMUR CEMENTED F2L| NR072Z / AS COLUMBUS REV F TIB.OFFSET CEMENT.T1+| NR113M / COLUMBUS REV F MC GLID.SURF.T1/1+ 16MM| NR195Z / AS TIBIA OFFSET STEM D15X92MM CEMENTED| NR246Z / AS COLUMBUS TIB.HEMI-SP.T1/1+ 15MM RL/LM| NR292Z / AS FEMUR EXTENS.STEM 6° D15X77 CEMENTED| NR400Z / AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR.| NR462Z / AS COLUMBUS REV FEM.SPACER DIST.F2 5MM| NR462Z / AS COLUMBUS REV FEM.SPACER DIST.F2 5MM