BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS VEGA PS FEMORAL COMP.CEMENTED F7L

    MDR report key: 9781868 · Received March 3, 2020

    Report

    Report Number
    9610612-2020-00034
    Event Type
    Injury
    Date Received
    March 3, 2020
    Date of Event
    December 16, 2019
    Report Date
    April 27, 2020
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    PMA / PMN Number
    K101281
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00027 ((B)(4) NX057Z). INVESTIGATION RESULTS: NO PRODUCT AT HAND - THEREFORE AN INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS AND FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THESE BATCHES. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE FAILURE. IT COULD BE POSSIBLE THAT THE FAILURE IS USAGE RELATED. 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 DEFINITIVE ROOT CAUSE FOR THE MENTIONED FAILURE. THERE ARE NO HINTS FOR A MATERIAL PROBLEM. ACCORDING TO THE QUALITY STANDARD AND DEVICE HISTORY RECORD FILES A MATERIAL DEFECT AND PRODUCTION ERROR WAS NOT FOUND IT COULD BE POSSIBLE THAT THERE WERE PROBLEMS WITH THE CEMENT TECHNIQUE. POTENTIAL SOURCES OF FAULTS RELATING TO THE CEMENT: · THE PROCESSING TIME OF THE USED CEMENT WAS EXCEEDED; · WRONG TEMPERATURE; · UNFAVOURABLE STORAGE; · THE AGE OF THE CEMENT; · WRONG HANDLING WITH THE CEMENT.

    Additional Manufacturer Narrative · 1

    ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00027 ((B)(4) NX057Z). 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 VEGA IMPLANT (FEMORAL COMPONENT), PER INFORMATION PROVIDED BY MEDWATCH 5092437/5092452. THE PATIENT WAS ORIGINALLY IMPLANTED WITH VEGA TOTAL KNEE COMPONENTS ON (B)(6) 2017. THERE WAS POSTOPERATIVE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS. THE EXPLANT OCCURRED ON (B)(6) 2019. ADDITIONAL INFORMATION WAS NOT YET RECEIVED.. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00027 ((B)(4) NX057Z).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241952 AS VEGA PS FEMORAL COMP.CEMENTED F7L KNEE ENDOPROSTHESES JWH AESCULAP AG NX016Z 52119108

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R