BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE

    MDR report key: 15200032 · Received August 10, 2022

    Report

    Report Number
    9610612-2022-00238
    Event Type
    Injury
    Date Received
    August 10, 2022
    Report Date
    October 28, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    HRZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NEITHER A LOT NUMBER NOR MATERIAL NUMBER WERE PROVIDED, REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) COULD NOT BE PERFORMED. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY 4(5) X PROBABILITY OF OCCURRENCE 2(5)) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. IN THIS CASE THE PRODUCT RISK ANALYSIS IS ONLY CONDITIONALLY APPLICABLE, BECAUSE THE AREA OF THE AXIS BREAKAGE IS UNKNOWN. BOTH TYPES OF BREAKAGES WERE CONSIDERED SEPARATELY IN THE RISK ANALYSIS. EXPLANATION AND RATIONALE: ACCORDING TO THE SURGEON WHO MADE THE REVISION SURGERY, THE TIBIAL COMPONENT WAS FOUND TO BE MISROTATED, OFF-AXIS AND MISALIGNED. THIS COULD BE A HINT FOR A USAGE/PATIENT RELATED ERROR. WITHOUT FURTHER INFORMATION (SURGERY REPORT, X-RAY FIGURES ETC.) IS THIS ONLY SPECULATIVE. FURTHERMORE IT MUST BE MENTIONED THAT THE AREA OF THE AXIS BREAKAGE IS UNKNOWN. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. 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 INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE - AE-QAS-K521-55. ACCORDING TO THE COMPLAINT DESCRIPTION, THE REVISION SURGERY WAS ON (B)(6) 2022 DUE TO FRACTURE OF AXIS. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399376 COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE KNEE ENDOPROSTHESES HRZ AESCULAP AG AE-QAS-K521-55

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention