BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANATOMIC

    MDR report key: 17018780 · Received May 30, 2023

    Report

    Report Number
    3009590742-2023-00006
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    May 12, 2023
    Report Date
    May 30, 2023
    Manufacturer
    AMPLITUDE
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE MANUFACTURING HISTORY RECORDS OF THE BATCH 334199 CONFIRM THE NON-CONFORMITY OF THE LABELS, WITH THE PRESENCE OF THE REFERENCE ".1-0200833" CORRESPONDING TO AN SCORE® PATELLAR RESURFACING IMPLANT CEMENTED Ø 33 MM ON THE INTERNAL LABEL / PATIENT LABEL INSTEAD OF THE REFERENCE "1-0200833." CORRESPONDING TO AN ANATOMIC® FIXED BEARING INSERT SIZE 4 THICKNESS 10. THE INVESTIGATIONS REBEALS THAT THE ORIGIN OF THE INCIDENT IS DUE TO A COMPUTER MALFUNCTION DURING PRINTING OF THE LABELS. THIS ERROR HAS NOT BEEN DETECTED DURING INSPECTION BEFORE RELEASE. CAPA (CORRECTIVE ACTION AND PREVENTIVE ACTION) HAS BEEN INITIATED IN ORDER TO IMPLEMENT ACTIONS TO AVOID THE RECCURENCE. AS A PRECAUTIONARY MEASURE, AMPLITUDE IS PERFORMING A FIELD SAFETY NOTICE, AN ADVISORY NOTICE IS SENT TO THE INVOLVED CUSTOMERS. THE INVOLVED BATCH HAS NOT BEEN DISTRIBUTED IN US (NO PRODUCT ON US MARKET).

    Description of Event or Problem · 0

    IT WAS DETECTED THAT THE REFERENCE ON THE TRACEABILITY LABELS CORRESPONDS TO A SCORE® PATELLAR RESURFACING IMPLANT CEMENTED. 33 MM INSTEAD OF AN ANATOMIC® FIXED BEARING INSERT SIZE 4 THICKNESS 10. THE ERROR WAS DETECTED AFTER THE SURGERY, DURING THE CONSULTATION OF THE PATIENT RECORD BY THE PHARMACY. THERE WAS NO RELATED PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1617691 ANATOMIC ANATOMIC® FIXED BEARING INSERT SIZE 4 THICKNESS 10 JWH AMPLITUDE 1-0204740 334199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown