BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTAGE UHMWPE INSERT 58/28

    MDR report key: 5635037 · Received May 5, 2016

    Report

    Report Number
    3006946279-2016-00067
    Event Type
    Injury
    Date Received
    May 5, 2016
    Date of Event
    November 9, 2011
    Report Date
    April 7, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE NECESSARY MANUFACTURING HISTORY WAS NOT PROVIDED FOR REVIEW. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: DATE OF BIRTH - MONTH AND DAY NI. PMA 510(K): THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K101336. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 0001825034-2016-01481 / 01482 / 01483 & 3006946279-2016-00067). REMAINS IMPLANTED.

    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. AN INVESTIGATION OF THE COMPLAINT HAS BEEN PERFORMED CONSISTING OF A DOCUMENTARY REVIEW. THE REVIEW OF MANUFACTURING DHR SHOWS THAT PRODUCTS WERE MANUFACTURED ACCORDING TO THE PRE-DEFINED SPECIFICATIONS. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4). ACCORDING TO THE AVAILABLE DATA, THE EXACT ROOT CAUSE OF THE INCIDENT CAN'T BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS TREATED FOR AN INFECTION OF UNKNOWN ORIGIN APPROXIMATELY 30 DAYS AFTER IMPLANTATION. AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED ON THE LEFT HIP HOWEVER NO PRODUCT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290991 AVANTAGE UHMWPE INSERT 58/28 PROSTHESIS, HIP LPH BIOMET FRANCE S.A.R.L. N/A 0000482775

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention