BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS COLUMBUS REV F FEMUR ZEMENTIERT F5L

    MDR report key: 9286213 · Received November 6, 2019

    Report

    Report Number
    9610612-2019-00748
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    October 9, 2019
    Report Date
    December 12, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    PMA / PMN Number
    K083772
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ASSOCIATED MEDWATCH: 9610612-2019-00793. ADDITIONAL INFORMATION SECTION D: UPDATED PRODUCT INFORMTION: LOT NUMBER: 52222426 (NR005Z) INVOLVED COMPONENTS: 500472139 NR250Z 500472140 NR475Z 500472141 NR485Z 500472142 NX043 500472143 NR585Z 500472145 NR186Z 500472210 NR409Z 500472211 NR626M PRELIMINARY INVESTIGATION RESULTS:(PREPARED PRIOR TO UPDATED PRODUCT INFORMATION) MANUFACTURING SIDE WE RECEIVED A COMPLAINT ABOUT A COLUMBUS REVISION TKA FROM USA. THERE ARE ONLY LITTLE INFORMATION AVAILABLE. POST-OPERATIVE MEDICAL INTERVENTION WAS NECESSARY INVESTIGATION NO PRODUCT AT HAND, THEREFORE A FAILURE DESCRIPTION IS NOT POSSIBLE. PICTORIAL DOCUMENTATION THERE ARE NO FIGURES AVAILABLE. BATCH HISTORY REVIEW A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS WAS NOT POSSIBLE BECAUSE THE LOT NUMBER IS UNKNOWN. CONCLUSION AND ROOT CAUSE BASED ON THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE FOR THE FAILURE. RATIONALE IN THE LIGHT OF THE SMALL AMOUNT OF INFORMATION RECEIVED AND DUE THE CIRCUMSTANCE THAT WE DID NOT RECEIVE THE COMPLAINED DEVICES FOR INVESTIGATION, IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE FOR THE MENTIONED FAILURE. CORRECTIVE ACTION ACCORDING TO SOP SA-DE13-M-4-2-04-000-0 (CORRECTIVE ACTION & PREVENTIVE ACTION) A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A COLUMBUS DEVICE. IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN AND HAD A REVISION SURGERY TO REMOVE A LOOSE COLUMBUS REVISION TOTAL KNEE ARTHROPLASTY (TKA). THE PATIENT WAS IMPLANTED WITH ANOTHER COMPANY'S REVISION TKA SYSTEM. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). SINCE NO MATERIAL NUMBER HAS BEEN PROVIDED BY THE REPORTER, WE EXEMPLARILY USED K083772 AND JWH AS PRODUCT CODES FOR THE COLUMBUS KNEE PROSTHESIS ASSUMING THAT THE EFFECTED PRODUCT WAS A REVISION KNEE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082470 AS COLUMBUS REV F FEMUR ZEMENTIERT F5L KNEE ENDOPROSTHESES JWH AESCULAP AG NR005Z 52222426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NR186Z-500472145| NR250Z-500472139| NR409Z-500472210| NR475Z-500472140| NR485Z-500472141| NR585Z-500472143| NR626M-500472211| NX043-500472142