BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND STAND PE CUP D42 +6MM

    MDR report key: 11613122 · Received April 5, 2021

    Report

    Report Number
    1818910-2021-06932
    Event Type
    Injury
    Date Received
    April 5, 2021
    Date of Event
    March 8, 2021
    Report Date
    March 8, 2021
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    PHX
    UDI-DI
    10603295027546
    PMA / PMN Number
    K120174
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION SINCE RELEASE FOR DISTRIBUTION. 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. 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). WHERE THE LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 1

    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 · 1

    THE PATIENT SHOULDER WAS REVISED TO ADDRESS DISLOCATION FROM REVERSE TSA, AFTER WORKING WITH HIS HORSES. WAS REVISED FROM A +0 TO +2 GLENOSPHERE AND A +6 TO +9 POLY. NO DELAY IN SURGERY. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512108 DXTEND STAND PE CUP D42 +6MM DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP PHX DEPUY FRANCE SAS - 3003895575 130742206 5346818 10603295027546

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention DXTEND GLENOSPHERE ECC D42MM| DXTEND STAND PE CUP D42 +6MM| DXTEND GLENOSPHERE ECC D42MM| DXTEND STAND PE CUP D42 +6MM