BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXTEND GLENOSPHERE ECC D42MM

    MDR report key: 5011637 · Received August 18, 2015

    Report

    Report Number
    1818910-2015-28428
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    August 12, 2015
    Report Date
    October 7, 2015
    Manufacturer
    3003895575 DEPUY FRANCE S.A.S
    Product Code
    HSD
    PMA / PMN Number
    PK120174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    CORRECTION: MANUFACTURING FACILITY: (B)(4). THE DEVICE ASSOCIATED TO THE COMPLAINT WAS RETURNED FOR ANALYSIS. THE DHR ANALYSIS PERFORMED DID NOT REVEAL ANY ANOMALIES THAT COULD BE RELATED TO THE ISSUE REPORTED ON THE COMPLAINT. A SEARCH INTO THE COMPLAINTS DATABASE WAS PERFORMED, NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE AFFECTED PRODUCT CODES AND LOTS COMBINATIONS. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED. THE INCIDENT COULD HAVE OCCURRED DURING USE, FROM AN ASSEMBLY NOT IN THE AXIS. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DURING IMPLANTATION OF THE 42 ECC GLENOSPHERE, THE SURGEON WAS HAVING TROUBLE GETTING THE IMPLANT TO SCREW INTO THE METAGLENE THE SURGEON WAS USING PROPER TECHNIQUE BY REVERSING THE SCREWDRIVER COUNTER CLOCKWISE, AND THEN CLOCKWISE TO SEAT THE GLENOSPHERE. AFTER MULTIPLE TRIES OF THIS NOT WORKING, THE SURGEON BACKED THE GLENOSPHERE OFF OF THE METAGLENE TO SURVEY THE IMPLANT. IT WAS THEN WHEN THE SURGEON WAS CONCERNED OF CROSS THREADING. ULTIMATELY, THE SURGEON CHOOSE TO USE ANOTHER OPTION OF GLENOSPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545576 DXTEND GLENOSPHERE ECC D42MM SHOULDER HEAD/GLENOSPHERE HSD 3003895575 DEPUY FRANCE S.A.S 5248352

    Patients

    Seq Age Sex Outcome Treatment
    1