BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTAGE UHMWPE INSERT 56/28

    MDR report key: 5717547 · Received June 10, 2016

    Report

    Report Number
    3006946279-2016-00105
    Event Type
    Injury
    Date Received
    June 10, 2016
    Date of Event
    May 9, 2016
    Report Date
    May 11, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LPH
    PMA / PMN Number
    PK101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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 OR DEVIATION. EXPLANT DATE - COULD BE (B)(6) 2016, HOWEVER, WE HAVE NO INFORMATION ON WHICH DEVICES WERE EXPLANTED. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4), BUT IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT WILL BE FILED, AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K101336. THIS REPORT IS 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 3006946279-2016-00105 & 3002806535-2016-00344). RETURN EXPECTED, NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE REVIEW OF MANUFACTURING DHR SHOWS THAT PRODUCTS WERE MANUFACTURED ACCORDING TO THE PRE-DEFINED SPECIFICATIONS. THE PRODUCT INSPECTION REVEALS THAT THE DEVICE SHOWS NORMAL WEAR MARKS ON THE EXTERNAL SURFACE AND THE INNER SURFACE SHOWS MARKS RELATED TO HEAD AND INSERT CONTACT. THE DIMENSIONAL MEASURES OF THE INSERT SHOWS SLIGHT VARIATIONS FROM THE ACCEPTED TOLERANCE, NEVERTHELESS THESE VARIATIONS ARE RELATED TO DEVICE NORMAL WEAR AND ARE NOT RELEVANT TO LEAD TO A DISLOCATION FROM THE HEAD. ACCORDING TO THE AVAILABLE DATA, AND IN ABSENCE OF THE SCAN THE ACTUAL DEVICE COULD HAVE LED TO THE ROOT CAUSE OF THE REPORTED DISLOCATION. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS REVISED 25 DAYS POST-IMPLANTATION DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372264 AVANTAGE UHMWPE INSERT 56/28 PROSTHESIS, HIP LPH BIOMET FRANCE S.A.R.L. N/A 0000834700

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R