BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER INSERT 32ID X 48OD

    MDR report key: 21552408 · Received March 7, 2025

    Report

    Report Number
    1818910-2025-03656
    Event Type
    Injury
    Date Received
    March 7, 2025
    Date of Event
    January 1, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MRA
    UDI-DI
    10603295012344
    PMA / PMN Number
    P070026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. PRODUCT DESCRIPTION: DELTA CER INSERT 32ID X 48OD. PRODUCT CODE: 121882748. LOT NUMBER: 9043227. MANUFACTURING DATE: 31-JAN-2019. EXPIRY DATE: 31-DEC-2023. QUANTITY MANUFACTURED: (B)(4). IFU REFERENCE: 78002788. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT ==> PRODUCT DESCRIPTION: DELTA CER INSERT 32ID X 48OD. PRODUCT CODE: 121882748. LOT NUMBER: 9043227. MANUFACTURING DATE: 31-JAN-2019. EXPIRY DATE: 31-DEC-2023. QUANTITY MANUFACTURED: (B)(4). IFU REFERENCE: 78002788. DEVICE HISTORY REVIEW ==> A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: E3 INITIAL REPORTER OCCUPATION: LAWYER. 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

    IT WAS REPORTED THAT PATIENT RECEIVED HIP-TEP LEFT. THE PATIENT UNDERWENT REVISION DUE TO THE HIP SOCKET IMPLANTED TOO STEEPLY, THE CERAMIC INLAY BROKE, CAUSING SEVERE PAIN, IMPAIRED MOVEMENT AND SQUEAKING NOISES AND ALL THAT STRONG, LASTING FOR MONTHS OR SO. INCREASING PAIN LED TO MORE AND MORE RESTRICTED MOVEMENT AND TO THE USE OF STRONG PAINKILLERS. AFFECTED SIDE: LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862309 DELTA CER INSERT 32ID X 48OD HIP CERAMIC ACETABULAR LINERS MRA DEPUY ORTHOPAEDICS INC US 9043227 10603295012344

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention APEX HOLE ELIM POSITIVE STOP| CORAIL2 STD SIZE 9| DELTA CER HEAD 12/14 32MM +1| PINN 100 W/GRIPTION 48MM