BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX +4 10D 36IDX52OD

    MDR report key: 17022537 · Received May 30, 2023

    Report

    Report Number
    1818910-2023-11165
    Event Type
    Injury
    Date Received
    May 30, 2023
    Date of Event
    May 18, 2023
    Report Date
    May 30, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295016403
    PMA / PMN Number
    K072963
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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: THE LOT 1111465 DOES NOT REFLECT A VALID FINISHED GOODS LOT NUMBER. THEREFORE, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED AS NO VALID FINISHED GOODS LOT NUMBER WAS PROVIDED FOR THIS DEVICE.

    Description of Event or Problem · 0

    PATIENT UNDERWENT HEAD/LINER EXCHANGE FOR INFECTION. NO SURGICAL DELAY WAS THERE. DOI: UNKNOWN DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915036 ALTRX +4 10D 36IDX52OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US 1221-36-152 1111465 10603295016403

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention S-ROM M HEAD 36MM +3