BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX DELTA MODULAR CERAMIC HEAD

    MDR report key: 6646349 · Received June 16, 2017

    Report

    Report Number
    3002806535-2017-00489
    Event Type
    Malfunction
    Date Received
    June 16, 2017
    Report Date
    March 28, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PK131684
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS AND VIGILANCE ENGINEER FOR INVESTIGATION. SUMMARY OF INVESTIGATION: VISUAL CHECKS A VISUAL CHECK WAS COMPLETED ON THE RETURNED DEVICE AND PACKAGING WITH THE FOLLOWING OBSERVATION:- HAIR PRESENT BETWEEN THE TOP FOAM AND TYVEK LID. NO DAMAGE TO CARTON OR SLEEVE. THE TYVEK LID WAS SECURED ON ONE SIDE OF THE BLISTER BY SURGICAL TAPE. NO DAMAGE TO THE BLISTER WALLS OR FOAMS. TYVEK LID ADHESION WAS CONSTANT AROUND THE CONTACT POINT OF THE BLISTER LID. 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. A REVIEW OF THE COMPLAINTS DATA BASE HAS FOUND NO SIMILAR REPORTED EVENTS FOR THESE ITEMS. COMPLAINT HAS BEEN CONFIRMED. 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 WHEN THE PACKAGING FOR A MODULAR HEAD WAS OPENED, A HAIR LIKE FOREIGN SUBSTANCE WAS FOUND IN THE STERILE PACKAGING. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428960 BIOLOX DELTA MODULAR CERAMIC HEAD PROSTHESIS, HIP JDI BIOMET UK LTD. N/A 3487802

    Patients

    Seq Age Sex Outcome Treatment
    1