BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS COLUMBUS REV F FEMUR CEMENTED F5L

    MDR report key: 7394118 · Received April 3, 2018

    Report

    Report Number
    9610612-2018-00155
    Event Type
    Malfunction
    Date Received
    April 3, 2018
    Date of Event
    December 11, 2017
    Report Date
    April 26, 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: COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NR005Z / AS COLUMBUS REV F FEMUR CEMENTED F5L. NR465Z / AS COLUMBUS REV FEM.SPACER DIST.F5 5MM. NR565Z / AS COLUMBUS REV FEM.SPACER POST.F5 5MM. NR440Z / AS FEMUR EXTENS.STEM 5° D20X177 CEM.LESS. NN484 / COLUMBUS PATELLA 3-PEGS P4 36X10MM. NR485Z / AS COLUMBUS REV FEM.SPACER DIST.F5 15MM. NR585Z / AS COLUMBUS REV FEM.SPACER POST.F5 15MM. NR400Z / AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR. BRAND NAME: AS COLUMBUS REV F FEMUR CEMENTED F5L MODEL AND CATALOG # NR005Z. EXPIRATION DATE:12/01/2022. APPOX. AGE OF DEVICE: 4 YEARS. 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 AVAILABLE 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 AND ANALYSIS IS NOT POSSIBLE BUT WE ASSUME BASED ON THE INFORMATION AVAILABLE THE ROOT CAUSE OF THIS 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. NO CAPA IS NECESSARY.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: USA. RECEIVED VIA MEDWATCH (MW5075169): EVENT DESCRIPTION PER MW REPORT: TOTAL KNEE FAILURE, GLOBAL TIBIA LOOSENED FIRST. ADDITIONAL INFORMATION HAS BEEN REQUESTED. FILE WILL BE UPDATED WHEN INFORMATION IS RECEIVED. ALL MED WATCH SUBMISSIONS RELATE TO THIS REPORT ARE: 9610612-2018-00171.

    Description of Event or Problem · 0

    COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NR005Z / AS COLUMBUS REV F FEMUR CEMENTED F5L. NR465Z / AS COLUMBUS REV FEM.SPACER DIST.F5 5MM. NR565Z / AS COLUMBUS REV FEM.SPACER POST.F5 5MM. NR440Z / AS FEMUR EXTENS.STEM 5° D20X177 CEM.LESS. NN484 / COLUMBUS PATELLA 3-PEGS P4 36X10MM. NR485Z / AS COLUMBUS REV FEM.SPACER DIST.F5 15MM. NR585Z / AS COLUMBUS REV FEM.SPACER POST.F5 15MM. NR400Z / AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236419 AS COLUMBUS REV F FEMUR CEMENTED F5L FEMUR IMPLANTS COLUMBUS JWH AESCULAP AG NR005Z 51913631

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NN484 / COLUMBUS PATELLA 3-PEGS P4 36X10MM.| NR005Z / AS COLUMBUS REV F FEMUR CEMENTED F5L.| NR400Z / AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR.| NR440Z / AS FEMUR EXTENS.STEM 5° D20X177 CEM.LESS.| NR465Z / AS COLUMBUS REV FEM.SPACER DIST.F5 5MM.| NR485Z / AS COLUMBUS REV FEM.SPACER DIST.F5 15MM.| NR565Z / AS COLUMBUS REV FEM.SPACER POST.F5 5MM.| NR585Z / AS COLUMBUS REV FEM.SPACER POST.F5 15MM.