BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER LOCKING SCREW

    MDR report key: 11783012 · Received May 6, 2021

    Report

    Report Number
    1818910-2021-09668
    Event Type
    Injury
    Date Received
    May 6, 2021
    Report Date
    April 28, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). 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. INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    DELTA XTEND CLAIM RECORD RECEIVED. CLAIM RECORD ALLEGES PERSONAL INJURIES FROM THE FAILURE OF THE DELTA XTEND REVERSE SHOULDER SYSTEM. DOI: UNKNOWN, DOR: UNKNOWN, UNKNOWN AFFECTED SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683917 UNKNOWN SHOULDER LOCKING SCREW SHOULDER LOCKING SCREW PHX DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK SHOULDER GLENOSPHERE DELTA XTEND| UNK SHOULDER HUMERAL CUP DELTA XTEND| UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND| UNK SHOULDER HUMERAL STEM DELTA XTEND| UNKNOWN SHOULDER LOCKING SCREW| UNKNOWN SHOULDER LOCKING SCREW| UNKNOWN SHOULDER METAGLENE| UNKNOWN SHOULDER NON-LOCKING SCREW| UNKNOWN SHOULDER NON-LOCKING SCREW