BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS VEGA PS TIBIAL PLATEAU CEMENTED T1+

    MDR report key: 10876247 · Received November 20, 2020

    Report

    Report Number
    9610612-2020-00685
    Event Type
    Injury
    Date Received
    November 20, 2020
    Report Date
    November 19, 2020
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS NOT AVAILABLE FOR INVESTIGATION. THEREFORE AN INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) WERE CHECKED FOR ALL AVAILABLE LOT NUMBERS AND WERE WITHIN SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THERE ARE 3 SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER: 52155557. (ALL REGISTERED AS INVOLVED COMPONENTS). THE DETERMINATION OF A DEFINITE ROOT CAUSE IS DUE TO THE NON-AVAILABILITY OF IMPORTANT INFORMATION AND THE DEVICE ITSELF NOT POSSIBLE. THE CONCLUSION FROM THE ROOT CAUSE ANALYSIS IS THAT A SYSTEMATIC DEVICE DEVIATION IS UNLIKELY SINCE THE RECEIVED COMPLAINTS ARE LIMITED TO CERTAIN HEALTH CARE INSTITUTIONS AND THEIR APPLICANTS. THE PARTICIPATION OF THE APPLICANTS IN THIS DEVIATION SCENARIO CANNOT BE EXCLUDED BY TODAY. BASED ON THE ROOT CAUSE ANALYSIS RESULT NO CORRECTIVE ACTIONS HAVE BEEN CARRIED OUT. AS A PREVENTIVE ACTION WE WERE IN CONTACT WITH THE AFFECTED HEALTH CARE INSTITUTIONS AND APPLICANTS IN ORDER TO REDUCE THE PROBABILITY OF RECURRENCE. THE COMPLAINTS WERE SUBMITTED TO AESCULAP AG AS A SUMMARY REPORT. IN ORDER TO EXAMINE FURTHER ACTIONS, ALL CASES FROM THE SUMMARY REPORT ARE PROCESSED AS VIGILANCE SUSPICION CASES AND ARE CONTINUOUSLY MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NX052Z-AS VEGA PS TIBIAL PLATEAU CEMENTED T1+. ACCORDING TO THE COMPLAINT DESCRIPTION, IT WAS REPORTED ON 15OCT2018, THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN, SWELLING, DIFFICULTY WALKING, LOOSENING AND INSTABILITY OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2016, AND THERE WAS NO REPORTED REVISION SURGERY. UPON REVIEW OF THE CIVIL ACTION CASE AND OBJECTIVE EVIDENCE, THE FOLLOWING PRODUCTS HAVE BEEN FOUND AS LISTED IN THE PATIENT'S MEDICAL RECORDS: NX009Z (PS FEMUR CEMENTED F4N LT), NX210 (PS PE INSERT T1/T1+, 10MM), NX052Z (PS TIBIA CEMENTED T1+), NN261Z (TIBIAL OBTURATOR D12MM, L7MM), NX043 (UNIVERSAL PATELLA P3). THE CEMENT USED WAS BIOMET COBALT HV BONE CEMENT (402282). THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342908 AS VEGA PS TIBIAL PLATEAU CEMENTED T1+ KNEE ENDOPROSTHETICS JWH AESCULAP AG NX052Z UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other