BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY-HEAD ACETABULAR SHELL 54MM POUROUS + HAP COATED

    MDR report key: 5870057 · Received August 11, 2016

    Report

    Report Number
    3002806535-2016-00683
    Event Type
    Injury
    Date Received
    August 11, 2016
    Date of Event
    July 15, 2016
    Report Date
    July 22, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    MEH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K021403.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. (B)(4). REVIEW OF DEVICE HISTORY RECORDS FOUND NO EVIDENCE OF PRODUCT NONCONFORMANCE. DIMENSIONAL ANALYSIS WAS PERFORMED ON THE SHELL AND THE DEVICE WAS FOUND CONFORMING TO PRINT. A DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED ON THE LOCKING RING. THERE WAS NO VISIBLE DAMAGE TO THE LOCKING RING AND THE LOCKING RING WAS PRESENT IN THE SHELL. A CONCLUSIVE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED; HOWEVER, CORRECTIVE ACTION HAS BEEN INITIATED FOR THE REPORTED ISSUE.

    Description of Event or Problem · 1

    WHILE THE SURGEON WAS IMPACTING THE ACETABULAR SHELL INTO THE PATIENT'S ACETABULUM, THE LOCKING RING FELL OUT. THE SURGEON TRIED TO PLACE THE RING BACK IN THE SHELL BUT WAS UNABLE. THEREFORE, THE SURGEON REAMED THE PATIENT'S ACETABULUM AGAIN AND IMPLANTED A LARGER SIZE ACETABULAR SHELL WITHOUT ISSUE. AS A RESULT OF THE EVENT, THERE WAS A TWENTY MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522521 MALLORY-HEAD ACETABULAR SHELL 54MM POUROUS + HAP COATED PROSTHESIS, HIP MEH BIOMET UK LTD. N/A 3585564

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention