BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTAGE INLAY SIZE 44 22,2

    MDR report key: 10725659 · Received October 23, 2020

    Report

    Report Number
    3006946279-2020-00214
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    October 13, 2020
    Report Date
    March 12, 2021
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LPH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. RECEIVED X-RAY DOES NOT SHOWS ANYTHING PARTICULARLY NOTICEABLE EXCEPT FROM THE LOOSENING OF THE DEVICE. THE PRODUCT ANALYSIS CAN'T BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. OTHER INFORMATION REVIEW: THE COMPATIBILITY OF THE DEVICES HAS BEEN REVIEWED. THE INSTRUCTIONS FOR USE OF THE CAGE HAS BEEN REVIEWED AND IT WAS NOTICED THAT THE AVANTAGE CUP AND THE MAX TI CAGE ARE NOT COMPATIBLE AS THE CAGE IS TO BE USED IN CONJUNCTION WITH ANY COMMERCIALLY AVAILABLE POLYETHYLENE ACETABULAR CUP. THE AVANTAGE CUP IS STAINLESS STEEL SO THIS MAKES THE COMBINATION NOT COMPATIBLE. A COMPLAINT EXTRACT WAS DONE REGARDING REVISION DUE TO PAIN AND LOOSENING: 1 COMPLAINT (1 PRODUCT), THIS ONE INCLUDED, HAS BEEN RECORDED ON AVANTAGE INLAY SIZE 44 Ø 22,2, REFERENCE P0560044, FROM JANUARY 01, 2017 TO FEBRUARY 08, 2021. 1 COMPLAINT (1 PRODUCT), THIS ONE INCLUDED, HAS BEEN RECORDED ON AVANTAGE INLAY SIZE 44 Ø 22,2, REFERENCE P0560044, BATCH 0000714004. 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. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT. 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 · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY WAS REVISED ON (B)(6) 2020 DUE TO HIP PAIN. SURGEON HAD XRAY, SHOWED MOVEMENT OF THE CUP AND CAGE. SURGEON OPERATED TO REMOVE CUP AND CAGE.

    Additional Manufacturer Narrative · 1

    (B)(4). LIST OF ASSOCIATED DEVICES: AVANTAGE CEMENTED CUP S44, REFERENCE (B)(4), BATCH 0000710631. MAX TI CAGE 52MM RIGHT M RIGHT, REFERENCE (B)(4) , BATCH 31093. 22.2MM DIA COCR MODULAR HEAD STANDARD NECK, REFERENCE (B)(4) , BATCH 428170. TI LOW PROFILE SCREW 6.5X30MM, REFERENCE (B)(4) , BATCH 138500. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(4). THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY WAS REVISED ON (B)(6) 2020 DUE TO HIP PAIN. SURGEON HAD XRAY, SHOWED MOVEMENT OF THE CUP AND CAGE. SURGEON OPERATED TO REMOVE CUP AND CAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1189214 AVANTAGE INLAY SIZE 44 22,2 NON-CONSTRAINED POLYETHYLENE ACETABULAR LINER LPH BIOMET FRANCE S.A.R.L. 0000714004

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R