BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGC REVISION KNEE TIBIAL AUGMENTATION

    MDR report key: 6673535 · Received June 28, 2017

    Report

    Report Number
    3002806535-2017-00535
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    May 29, 2017
    Report Date
    March 28, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K921182. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCTS HAVE BEEN RETURNED TO BIOMET (B)(4) LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS AND VIGILANCE ENGINEER FOR INVESTIGATION. SUMMARY OF INVESTIGATION: THE RETURNED DEVICE AND PACKAGING HAVE BEEN VISUALLY CHECKED WITH THE FOLLOWING OBSERVATIONS FOUND: POUCH WAS TORN TO THE EXACT WIDTH OF THE DEVICE. WHITE DISCOLORATION FROM POSSIBLE MOVEMENT OF THE DEVICE IN THE POUCH. CARDBOARD CARRIER HAD INDENTATIONS AND DAMAGED EDGES, POSSIBLE FROM TRANSPORTATION AND HANDLING BEING. NO DAMAGE TO THE BLISTER. GREYISH MARKING VISIBLE IN THE POUCH FROM POSSIBLE MOVEMENT OF THE DEVICE WHERE THE POUCH HAS RUBBED AGAINST THE POROUS COATING. THE MHR RELATED TO THE INVOLVED PRODUCT HAS BEEN REVIEWED AND DOES NOT SHOW ANY NON-CONFORMITY, REJECTION OR CONCESSION THAT COULD BE RELATED TO THE REPORTED EVENT. THE DEVICE POUCH WAS TORN AND MISTED WHEN RECEIVED FROM THE HOSPITAL. THE DEVICE EXPIRY DATE IS JUL-2017. THE DEVICE WAS CONFORMING TO THE PRE-DEFINED DRAWING AND PACKAGING SPECIFICATION WHEN MANUFACTURED IN 2007. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    IT WAS REPORTED THAT DURING INTERNAL INSPECTION, IT WAS FOUND THE INNER STERILE PACKAGING OF AN AUGMENT HAD A HOLE IN IT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454834 AGC REVISION KNEE TIBIAL AUGMENTATION PROSTHESIS, KNEE JWH BIOMET UK LTD. N/A 1329004

    Patients

    Seq Age Sex Outcome Treatment
    1