BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTAGE CEMENTED ACETABULAR CUP SIZE 48

    MDR report key: 10413044 · Received August 17, 2020

    Report

    Report Number
    3006946279-2020-00153
    Event Type
    Injury
    Date Received
    August 17, 2020
    Date of Event
    April 9, 2020
    Report Date
    August 17, 2020
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    KWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LIST OF PRODUCTS IMPLANTED: THE ORIGINAL AVANTAGE SHELL AND LINER WHERE IMPLANTED WITH A STRYKER. EXETER STEM AND A STRYKER 22 BALL HEAD WITH HERAEUS BONE CEMENT FOR THE CUP & THE STEM. THE PRODUCT DETAILS FOR THESE ITEMS ARE UNAVAILABLE. THE ORIGINAL AVANTAGE SHELL THAT WAS NOT REVISED REF P0463048, LOT 0001279524. THIS WAS SUPPORTED BY TM AUGMENT REF 00-4894-050-10, LOT 64290950. BONE SCREW X 2 REF 00-6624-065-30, LOT 64088045, REF 00-6624-065-40, LOT 64434233. FOREIGN REPORT SOURCE: (B)(6). NO FURTHER INFORMATION PROVIDED (X-RAYS, SURGICAL REPORT, PHOTOGRAPHS, LAB TEST), NO PRODUCT RETURNED, THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THEREFORE IT COULD NOT BE ANALYZED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE REVIEW OF THE STERILIZATION CERTIFICATE INDICATES THAT THE PRODUCTS WERE STERILIZED ACCORDING TO THE SPECIFICATION. WITHIN 3 YEARS, NO SIMIR COMPLAINT HAS BEEN REGISTERED REGARDING A REVISION DUE TO INFECTION ON AVANTAGE CEMENTED ACETABULAR CUP SIZE 48, REFERENCE P0463048, BATCH 0001279524. THE INSTRUCTIONS FOR USE HAVE BEEN REVIEWED AND IT WAS NOTICED THAT THE DEVICES USED IN ASSOCIATION WITH THE INLAY ARE NOT COMPATIBLE, ESPECIALLY THE STEM AND THE HEAD THAT ARE NOT MANUFACTURED BY ZIMMER BIOMET. THEREFORE, THE COMPATIBILITY OF THE WHOLE DEVICE IS NOT GUARANTEED. ACCORDING TO AVAILABLE DATA, ROOT CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED. HOWEVER, THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO THE PRODUCT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    REMOVAL OF AVANTAGE E1 INSERT, WASH OUT AND DEBRIDEMENT AND REINSERTION OF NEW INSERT. THE REVISION OF THE INSERT WAS DUE TO AN UNSPECIFIED INFECTION. THE ORIGINAL AVANTAGE SHELL AND LINER WHERE IMPLANTED WITH A STRYKER EXETER STEM AND A STRYKER 22 BALL HEAD WITH HERAEUS BONE CEMENT FOR THE CUP & THE STEM. THIS REPORT HANDLE THE INVESTIGATION MADE ON THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881285 AVANTAGE CEMENTED ACETABULAR CUP SIZE 48 PROTHESIS, HIP KWZ BIOMET FRANCE S.A.R.L. 0001279524

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R