BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS COLUMBUS REV F TIB.OFFSET CEMENT.T5

    MDR report key: 7394126 · Received April 3, 2018

    Report

    Report Number
    9610612-2018-00171
    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: NR079Z / AS COLUMBUS REV F TIB.OFFSET CEMENT.T5. NR061Z / AS COLUMBUS TIB.HEMI-SP.T5 10MM RM/LL. NR261Z / AS COLUMBUS TIB.HEMI-SP.T5 10MM RL/LM. NR150M / COLUMBUS REV F MC GLID.SURF.T5 10MM. NR188Z / AS TIBIA OFFSET STEM D18X132 CEMENTLESS. BRAND NAME: AS COLUMBUS REV F TIB.OFFSET CEMENT.T5. MODEL AND CATALOG # NR079Z. EXPIRATION DATE:11/01/2017. CONCOMITANT MEDICAL PRODUCTS: ADDED COMPONENTS. AGE OF THE 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 THE AVAILABLE LOT NUMBERS AND FOUND TO BE ACCORDING TO THE 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 AN 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 AND 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: 9610612-2018-00155.

    Description of Event or Problem · 0

    COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NR079Z / AS COLUMBUS REV F TIB.OFFSET CEMENT.T5. NR061Z / AS COLUMBUS TIB.HEMI-SP.T5 10MM RM/LL. NR261Z / AS COLUMBUS TIB.HEMI-SP.T5 10MM RL/LM. NR150M / COLUMBUS REV F MC GLID.SURF.T5 10MM. NR188Z / AS TIBIA OFFSET STEM D18X132 CEMENTLESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237214 AS COLUMBUS REV F TIB.OFFSET CEMENT.T5 TIBIA IMPLANTS COLUMBUS JWH AESCULAP AG NR079Z 51903836

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NR061Z / AS COLUMBUS TIB.HEMI-SP.T5 10MM RM/LL| NR079Z / AS COLUMBUS REV F TIB.OFFSET CEMENT.T5| NR150M / COLUMBUS REV F MC GLID.SURF.T5 10MM| NR188Z / AS TIBIA OFFSET STEM D18X132 CEMENTLESS| NR261Z / AS COLUMBUS TIB.HEMI-SP.T5 10MM RL/LM