BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANATOMIC

    MDR report key: 8150515 · Received December 11, 2018

    Report

    Report Number
    3009590742-2018-00002
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 12, 2018
    Report Date
    December 10, 2018
    Manufacturer
    AMPLITUDE
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT IS RELATED TO A MEDICAL DEVICE WHICH IS NOT CLEARED AND DISTRIBUTED IN US, BUT WHICH IS SIMILAR TO THE ANATOMIC SYSTEM (K161414) THE FIRST ELEMENTS OF THE INVESTIGATION PERFORMED WITH OUR SUB-CONTRACTORS SHOW THAT: THE REVIEW OF THE MANUFACTURING HISTORY RECORDS DOES NOT SHOW ANY NON-CONFORMITY OR ANOMALY. THE REVIEW OF THE MANUFACTURING PROCESS SHOWS THAT THERE WAS NO PROCESS MODIFICATIONS INVOLVING PRODUCT IN CONTACT WITH THE DEVICE. THE ONLY MODIFICATION OF THE PROCESS IS AN AUTOMATIZATION OF THE PASSIVATION MACHINE WITHOUT CHANGING THE PASSIVATION AGENT. THE REVIEW OF THE MANUFACTURING PROCESS SHOWS THAT THERE WAS NO MAINTENANCE OF THE EQUIPMENT INVOLVED IN THE CLEANING AND PACKAGING PROCESS DURING THE MANUFACTURING PERIOD. THE TRACEABILITY DATA SHOW THAT 10 PARTS WERE MANUFACTURED WITH THIS BATCH NUMBER. RESIDUES WERE OBSERVED ON 4 PARTS (2 DURING THE SURGERY INVOLVED IN THE INITIAL INCIDENT REPORT AND 2 DURING INSPECTION OF PARTS BY AMPLITUDE AFTER THE INCIDENT).THE RESIDUE IS OBSERVED ON THE UPPER SURFACE OF THE BASPELATE. NO RESIDUE WAS OBSERVED ON 4 PARTS DURING INSPECTION OF PARTS BY AMPLITUDE AFTER THE INCIDENT. 2 PARTS ARE IMPLANTED IN AUSTRALIA WITHOUT ANY RECORDED COMPLAINT. ACCORDING TO THE FIRST ELEMENTS OF THE INVESTIGATION, THE MOST PROBABLE ORIGIN IS A CONTAMINATION DURING THE PACKAGING PHASE. THE BATCH IS PARTIALLY CONCERNED BY THIS NON CONFORMITY. THE RETURNED PART FROM AUSTRALIA HAS BEEN SENT FOR A PHYSICO-CHEMICAL ANALYSIS IN ORDER TO DETERMINE THE NATURE OF THE RESIDUE AND INVESTIGATE FURTHER TO DETERMINE ITS ORIGIN. AS A PRECAUTIONARY MEASURE, AMPLITUDE HAS INITIATED A BATCH RECALL. NO CONCERNED PRODUCTS ARE ON THE US MARKET.

    Description of Event or Problem · 1

    DURING THE SURGERY, UPON OPENING THE ANATOMIC TIBIAL BASEPLATE, THE NURSE NOTED THAT THERE WAS A RESIDUE ON THE SIZE 4 TIBIAL BASEPLATE. CONSEQUENTLY, THE BASEPLATE WAS NOT IMPLANTED AND INSTEAD ANOTHER BASEPLATE WAS OPENED. THE REPLACEMENT TIBIAL BASEPLATE OF SAME BATCH NUMBER ALSO HAD A SLIGHT RESIDUE HOWEVER THIS WAS WIPED OFF BY THE NURSE AND IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993535 ANATOMIC TIBIAL BASEPLATE CEMENTED JWH AMPLITUDE 1-0204904 277196

    Patients

    Seq Age Sex Outcome Treatment
    1 Other