BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL ADVANTAGE CTA HD 48X18

    MDR report key: 2071476 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-05188
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSD
    PMA / PMN Number
    K000575
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    JOHNSON AND JOHNSON MEDICAL (B)(4) REPORTS: PATIENT HAD GLOBAL ADVANTAGE HEMIARTHROPLASTY / CTA HEAD INSERTED BY ANOTHER SURGEON ON (B)(6) 2003. PRESENTED TO PROF (B)(6) COMPLAINING OF INCREASED PAIN DECREASED ROM. XRAYS ATTACHED. REVISION SURGERY PERFORMED ON (B)(6) 2011. ORIGINAL IMPLANTS LISTED ABOVE WERE REMOVED CONVERTED TO A DELTA XTEND REVERSE SHOULDER. THE DEVISES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE DATABASES DID NOT SHOW ANY OTHER REPORTS WITH REGARDS TO THE REPORTED EVENT. REVIEW OF THE ATTACHED X-RAYS BY (B)(4) PRODUCT DEVELOPMENT CONCLUDED THE FOLLOWING: IT APPEARS THAT THERE WERE ALREADY CUFF MUSCLE ISSUES WHICH WOULD FALL IN LINE WITH THE NATURAL PROGRESSION OF SHOULDER ARTHROPLASTY. ROM DEGRADATION AND INCREASED PAIN WERE PROBABLY CAUSED BY A FAILING CUFF MUSCLE, NOT THE IMPLANT. SPECULATION ON THE REASON FOR REVISION CANNOT BE MADE, BUT IT DOES NOT APPEAR TO BE A FAILURE OF THE IMPLANT SYSTEM. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND / OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT HAD INCREASED PAIN & DECREASED ROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL ADVANTAGE CTA HD 48X18 87 HSD, KWS HSD DEPUY ORTHOPAEDICS, INC. NA V4TB1004

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention