BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND HUMERAL SPACER +9MM

    MDR report key: 12861776 · Received November 23, 2021

    Report

    Report Number
    1818910-2021-26195
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    November 4, 2021
    Report Date
    November 23, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HSD
    UDI-DI
    10603295027348
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #:(B)(4). 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

    THE PATIENT WAS REVISED DUE TO PRESENT OF INFECTION. I&D WASHOUT WITH IMPLANT EXCHANGE WERE PERFORMED. ALL COMPONENTS HAD SOLID FIXATION. ORIGINAL IMPLANTATION WAS (B)(6) 2020. SHE HAD ANOTHER WASHOUT IN (B)(6) 2021. DOI: (B)(6) 2020. (B)(6) 2021 (GLENOSPHERE, METAGLENE AND PE CUP DOR: (B)(6) 2021. RIGHT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758670 DXTEND HUMERAL SPACER +9MM DELTA XTEND IMPLANTS : SHOULDER HUMERAL SPACER HSD DEPUY ORTHOPAEDICS INC US 130730009 5378222 10603295027348

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention DXTEND MOD EPI 1 ECC RIGHT HA| DXTEND STAND PE CUP D38 +3MM| XTND GLENO ECC D38MM +2MM