BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VG CR MONO-LCK BRG 12X75

    MDR report key: 6957582 · Received October 18, 2017

    Report

    Report Number
    0001825034-2017-09088
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    September 13, 2015
    Report Date
    October 18, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK060525
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED BY ZIMMER BIOMET. THE COMPLAINT OF DAMAGED POLYETHYLENE IS CONFIRMED. THE CARTON DISPLAYED SIGNIFICANT SIGNS OF DAMAGE. THE INNER TRAY WAS FULLY INTACT AND THERE WAS NO BREACH OF STERILE BARRIER. THE SEAL TRANSFER ON THE TRAY DISPLAYS THAT A PROPER SEAL WAS CREATED. THE CAUSE OF THE DAMAGE TO THE IMPLANT CANNOT BE DETERMINED. THEREFORE, IT CANNOT BE DETERMINED IF THE IMPLANT LEFT BIOMET CONFORMING. THE POLYETHYLENE WAS REMOVED FROM THE BASE PLATE AND SECTIONED TO MEASURE THE OXIDATION INDEX CLOSE TO THE OVERMOLDED SECTION OF THE POLYETHYLENE WHERE FLAKING OCCURRED. THE OXIDATION INDEX WAS MEASURED PER ZWI 29.524 AT THE ZIMMER RESEARCH FACILITY (WORK ORDER NUMBER (B)(4)). THE MAXIMUM NORMALIZED OXIDATION INDEX MEASURED ACROSS THIN SECTIONS OF THE PART WAS 8.44. THERE WAS ALSO EVIDENCE OF WHITE BANDING ON THE THIN SECTIONS. THE WHITE BANDING AND OXIDATION INDEX SUGGEST THAT THE MATERIAL WAS EXPOSED TO OXYGEN AND OXIDIZED ON THE SHELF. THE RESULTING "FLAKING" OF THE POLYETHYLENE MATERIAL WAS LIKELY THE RESULT OF OXIDATION COMBINED WITH RESIDUAL STRESS FROM DIRECT MOLDING. THE BARRIER FILM BAG USED TO LIMIT THE POLYETHYLENE'S EXPOSURE TO OXYGEN WAS NOT RETURNED WITH THE DEVICE. THE DEVICE WAS RETURNED WITH THE TYVEK LID, BLISTER CARTON, AND A NYLON BAG LIKE THOSE USED TO WRAP FEMORAL COMPONENTS. AN INVESTIGATION OF THE ROUTER SHOWS THAT THE BARRIER FILM BAG WAS A PART OF THE BILL OF MATERIALS AND THAT THE VACUUM SEALING STEP WAS INDICATED ON THE ROUTER AS COMPLETE. THIS MAY SUGGEST THAT THE BARRIER FILM BAG WAS COMPROMISED DURING THE SAME DISTRIBUTION CONDITIONS THAT LED TO THE PACKAGING DAMAGE MENTIONED IN THE USE SYNOPSIS. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. 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. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL TKA ON (B)(6) 2015; THE PACKAGING FOR THE TIBIAL COMPONENT WAS DAMAGED AND POLYETHYLENE FLAKES WERE OBSERVED ON THE PRODUCT. A DIFFERENT IMPLANT WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739461 VG CR MONO-LCK BRG 12X75 PROTHESIS KNEE JWH ZIMMER BIOMET, INC. NI 828340

    Patients

    Seq Age Sex Outcome Treatment
    1