BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 36MM +5

    MDR report key: 15462017 · Received September 21, 2022

    Report

    Report Number
    1818910-2022-18385
    Event Type
    Injury
    Date Received
    September 21, 2022
    Date of Event
    March 1, 2018
    Report Date
    September 21, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    UDI-DI
    10603295033622
    PMA / PMN Number
    P070026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: BFARM DHR REVIEW REQUEST: PRODUCT DESCRIPTION: DELTA CER HEAD 12/14 36MM +5. PRODUCT CODE: 136536320. LOT NUMBER: 7942864. PLEASE PROVIDE: 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 07/2014. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE. NO NON CONFORMANCES OR DEVIATIONS WERE IDENTIFIED. 4) EXPIRY DATE: 06/2019. 5) IFU REFERENCE: 090200701 IFU TOT HIP PROS REV. N CORRECTED: H4.

    Description of Event or Problem · 0

    WITHIN MEDICAL DOCUMENTATION OF (B)(4) IT BECAME OBVIOUS THAT PATIENT WAS REVISED BEFORE: REVISION OF HIP HEAD AND PE INLAY LEFT HIP BECAUSE OF DISLOCATION. DOI: (B)(6) 2014; DOR: (B)(6) 2018; UNKNOWN SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533515 DELTA CER HEAD 12/14 36MM +5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LZO DEPUY ORTHOPAEDICS INC US 1365-36-320 7942864 10603295033622

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention DELTA CER HEAD 12/14 36MM +5| PINN MAR +4 10D 36IDX56OD