BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL AP CTA HUMRL HEAD 48X18

    MDR report key: 2962981 · Received February 15, 2013

    Report

    Report Number
    1818910-2013-12422
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 17, 2013
    Report Date
    February 14, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    HSD
    PMA / PMN Number
    PK082715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. ADDITIONALLY, RESEARCH USING THE (B)(4) SYSTEM INDICATES THAT SEVERAL OTHER DEVICES FROM THE REPORTED LOT HAVE BEEN DELIVERED AND ARE CONSIDERED SUCCESSFULLY IMPLANTED AS NO OTHER REPORTS HAVE BEEN RECEIVED. REVIEW OF PROVIDED PATIENT X-RAYS BY A DEPUY (B)(4) PRODUCT MANAGER FINDS THAT THE PROVIDED X-RAYS INDICATE THAT THE HUMERUS IS RIDING UP DUE TO POOR ROTATOR CUFF MUSCLES, ALSO SEEN IS HUMERAL HEAD ARTICULATION AGAINST THE UPPER SECTION OF THE GLENOID AND CORACOACROMIAL ARCH. HYPOTHETICALLY, THIS COULD CAUSE PAIN. HOWEVER, DUE TO THE LACK OF PRODUCT AND ADDITIONAL INFORMATION THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    REVISION OF GLOBAL AP TO DELTA XTEND. REASON FOR REVISION GIVEN AS PAIN. NO INFECTION PRESENT. UPDATE: (B)(4) 2013 PRODUCT/LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66824 GLOBAL AP CTA HUMRL HEAD 48X18 HUMERAL HEAD HSD DEPUY ORTHOPAEDICS C47HL1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention