BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLOBAL AP HUMERAL STEM 14MM

    MDR report key: 7905506 · Received September 25, 2018

    Report

    Report Number
    1818910-2018-70331
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    August 31, 2018
    Report Date
    August 31, 2018
    Manufacturer
    DEPUY ORTHOPAEDIC INC, 1818910
    Product Code
    HSD
    UDI-DI
    10603295005551
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # PC-(B)(4). INVESTIGATION SUMMARY EVALUATION OF THE RETURNED DEVICE/PACKAGING COMPONENTS DID NOT IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT. 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. DEVICE HISTORY LOT PRODUCT CODE (B)(4), LOT NUMBER 201351 DEVICE HISTORY REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. 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

    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

    NO SECONDARY SEAL AROUND IMPLANT AND IMPLANT STICKERS LOOSE IN THE BOX. NO STERILIZATION EVIDENCE ATTACHED TO INNER IMPLANT PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747248 GLOBAL AP HUMERAL STEM 14MM GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS HSD DEPUY ORTHOPAEDIC INC, 1818910 201351 10603295005551

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR