BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVATION XF TIBIA CEMENTED T5 RM

    MDR report key: 7114385 · Received December 13, 2017

    Report

    Report Number
    9610612-2017-00596
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Report Date
    January 26, 2018
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    HRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    COUNTRY COMPLAINT: (B)(6). IT IS REPORTED THAT THE TIBIA BROKE. OPERATING ROOM REPORTS AND X-RAY WILL BE RECEIVED SOON.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDR ADDED, ADDITIONAL INFORMATION FOLLOW UP. ALL MED WATCH SUBMISSIONS RELATED TO THIS RELATED TO THIS REPORT ARE: (B)(4). THE DEVICE FOR INVESTIGATION WAS NOT RETURNED BECAUSE THE UNIVATION XF TIBIA CEMENTED T5 RM IS TILL IMPLANTED. NO X-RAYS ARE AVAILABLE. POST-OPERATIVE MEDICAL INTERVENTION WILL BE NECESSARY. DUE TO THE CIRCUMSTANCE THAT THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, A FAILURE IS NOT POSSIBLE TO DETERMINE. A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS WAS NOT POSSIBLE BECAUSE THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION AVAILABLE IT IS HARDLY POSSIBLE TO DETERMINE A CONCLUSION OR ROOT CAUSE. THERE ARE POSSIBLE REASON FOR A TIBIA FRACTURE: TOO DEEP A CUT. TOO DEEP A CUT ON THE SAGITTAL CUT WITH THE RECIPROCATING SAW. TOO HIGH FORCES WHILE TIBIA FINAL PREPARATION (HAMMER) OR WHILE FINAL TIBIA IMPLANTATION. ACCORDING TO SOP A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). ADDITIONAL MDR ADDED, ADDITIONAL INFORMATION FOLLOW-UP. COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NO183K / UNIVATION XF FEMUR CEMENTED F4 RM. NL473 / UNIVATION F MENISCAL COMP.T4 RM/LM 7MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891354 UNIVATION XF TIBIA CEMENTED T5 RM TIBIA IMPLANTS UNIVATION HRZ AESCULAP IMPLANT SYSTEMS NO160K

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NL473 / UNIVATION F MENISCAL COMP.T4 RM/LM 7MM| NO183K / UNIVATION XF FEMUR CEMENTED F4 RM