BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS COLUMBUS REV F FEMUR CEMENTED F4L

    MDR report key: 16572962 · Received March 20, 2023

    Report

    Report Number
    9610612-2023-00054
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    October 22, 2021
    Report Date
    July 19, 2023
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    PMA / PMN Number
    K083772
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6 - CODES UPDATED. INVESTIGATION: DUE TO THE CIRCUMSTANCE THAT NO PRODUCT WAS PROVIDED AN INVESTIGATION IS NOT POSSIBLE. REVIEW OF BATCH HISTORY RECORDS: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE DUE TO THE CIRCUMSTANCE THAT THE ROOT CAUSE FOR THE LOOSENING COULD NOT BE CLEARLY DETERMINED THE PRA IS ONLY CONDITIONALLY APPLICABLE; SEVERITY IS 4(5) AND PROBABILTY 2(5). EXPLANATION AND RATIONALE: ON THE BASIS OF THE CURRENT INFORMATION AND WITHOUT THE PRODUCT FOR INVESTIGATION, A CLEAR CONCLUSION REGARDING THE IMPLANT LOOSENING CANNOT BE DRAWN. THERE ARE SEVERAL AND OFTEN COMPLEX ROOT CAUSES FOR AN IMPLANT LOOSENING: POSSIBLY DUE TO SEPTIC CONDITIONS OR, FOR EXAMPLE, TO INCORRECT LOADING, TOO EARLY OR TOO HIGH LOADING, WHICH MAY ALSO HAVE OCCURRED LONG BEFORE THE ONSET OF LOOSENING, SUBOPTIMAL POSITIONING (DUE TO THE PATIENT), INAPPROPRIATE CHOICE OF IMPLANT, INAPPROPRIATE SURGICAL PROCEDURE OR INAPPROPRIATE CEMENTING TECHNIQUE, AND MANY OTHERS. CONCLUSION AND PREVENTIVE MEASURES: THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NR004Z - AS COLUMBUS REV F FEMUR CEMENTED F4L. ACCORDING TO THE COMPLAINT DESCRIPTION, THE FIRST SURGERY WAS PERFORMED IN (B)(6) 2018 WITH FOREIGN IMPLANTS. A REVISION SURGERY WITH COLUMBUS IMPLANTS WAS PERFORMED DUE TO ASEPTIC LOOSENING. A RE-REVISION SURGERY WAS PERFORMED DUE TO THE REPEATED LOOSENING. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE: (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2023-00054 (400591991 - NR004Z) 9610612-2023-00055 (400591994 - NR074Z) INVOLVED COMPONENTS NR574Z - AS COLUMBUS REV FEM. SPACER POST. F4 10MM - LOT UNKNOWN NR464Z - AS COLUMBUS REV FEM. SPACER DIST. F4 5MM - LOT UNKNOWN NR180Z - AS TIBIA OFFSET STEM D20X92 CEMENTLESS - LOT UNKNOWN NR622M - COLUMBUS REV F HC GLID. SURF. T2/2+ 14MM - LOT UNKNOWN NX043 - PATELLA 3-PEGS P3 - LOT UNKNOWN AE-QAS-K521-53 - COLLECT. NO. QAS KNEE IMPLANTS COLUMBUS - LOT UNKNOWN.

    Description of Event or Problem · 0

    ASSOCIATED MEDWATCH-REPORTS: 9610612-2023-00054 (400591991 - (B)(4)). 9610612-2023-00055 (400591994 - (B)(4)). INVOLVED COMPONENTS (B)(4) - AS COLUMBUS REV FEM.SPACER POST.F4 10MM - LOT UNKNOWN. (B)(4) - AS COLUMBUS REV FEM.SPACER DIST.F4 5MM - LOT UNKNOWN. (B)(4) - AS TIBIA OFFSET STEM D20X92 CEMENTLESS - LOT UNKNOWN. (B)(4) - COLUMBUS REV F HC GLID.SURF.T2/2+ 14MM - LOT UNKNOWN. (B)(4) - PATELLA 3-PEGS P3 - LOT UNKNOWN. AE-QAS-K521-53 - COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS - LOT UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767454 AS COLUMBUS REV F FEMUR CEMENTED F4L KNEE ENDOPROSTHETICS JWH AESCULAP AG NR004Z

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention AE-QAS-K521-53 - LOT UNKNOWN| AE-QAS-K521-53 - LOT UNKNOWN| NR180Z - LOT UNKNOWN| NR180Z - LOT UNKNOWN| NR464Z - LOT UNKNOWN| NR464Z - LOT UNKNOWN| NR574Z - LOT UNKNOWN| NR574Z - LOT UNKNOWN| NR622M - LOT UNKNOWN| NR622M - LOT UNKNOWN| NX043 - LOT UNKNOWN| NX043 - LOT UNKNOWN