BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EA DELTA CER INSERT 36IDX54OD

    MDR report key: 16208616 · Received January 19, 2023

    Report

    Report Number
    1818910-2023-01533
    Event Type
    Injury
    Date Received
    January 19, 2023
    Date of Event
    January 1, 2023
    Report Date
    January 19, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT NUMBER - 121881754, LOT NUMBER - 8181898, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. DEVICE HISTORY REVIEW: THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF ANY PRE-EXISTING MATERIAL DEFECT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION RECEIVED FROM (B)(6). PLEASE BE ADVISED THAT OUR LOCAL LAWYERS HAVE RECENTLY CONFIRMED THAT THAT IT WAS THE CERAMIC LINER THAT FRACTURED. INITIAL REPORTER OCCUPATION: LAWYER. DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    ASR LEGAL DOCUMENT RECEIVED. ASR CLAIM LETTER ENGLISH TRANSLATION RECORD RECEIVED. CLAIM LETTER ALLEGES INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155672 EA DELTA CER INSERT 36IDX54OD PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US 8181898

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention CORAIL2 STD SIZE 13| DELTA CER HEAD 12/14 36MM +1.5| EA DELTA CER INSERT 36IDX54OD| PINNACLE SECTOR II CUP 54MM