BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER PERIARTICULAR DISTAL LATERAL FIBULAR LOCKING PLATE

    MDR report key: 6486757 · Received April 12, 2017

    Report

    Report Number
    0001822565-2017-02227
    Event Type
    Injury
    Date Received
    April 12, 2017
    Date of Event
    March 13, 2017
    Report Date
    June 9, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWC
    PMA / PMN Number
    PK070906
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. AS RETURNED, CORROSION IS NOTED ON THE PLATE. DIMENSION TAKEN IS WITH SPEC. THE SCREW REMAINS IN THE HOLE WITH CORROSION AROUND IT. SEM ANALYSIS WAS COMPLETED ON THE RETURNED PRODUCT. PER THE SEM ANALYSIS: NO ACTIVE CORROSION SITES WERE OBSERVED IN THE AREA OF THE OBSERVED DEBRIS ON THE BONE PLATE UNDER SEM ANALYSIS. SEM ANALYSIS SHOWS DEBRIS ON THE SURFACE OF THE BONE PLATE. EDS AND SEM ANALYSIS OF THE DEBRIS AROUND THE SCREW ON THE MEDIAL SIDE OF THE BONE PLATE INDICATED THIS DEBRIS IS CONSISTENT WITH A DEPOSITED CORROSION PRODUCT. SEVERAL PITS WERE OBSERVED ON THE HEAD OF THE SCREW. EDS AND SEM ANALYSIS OF PITS ON THE SCREW INDICATE THESE PITS ARE CONSISTENT WITH ACTIVE CORROSION SITES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR EVALUATION. ONCE THE EVALUATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001822565-2017-02228).

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING A PLANNED TRAUMA FIXATION PLATE REVISION, OXIDATION COULD BE FOUND ON THE PROSTHESIS WHEN IT WAS REMOVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268432 ZIMMER PERIARTICULAR DISTAL LATERAL FIBULAR LOCKING PLATE SCREW, FIXATION HWC ZIMMER, INC. N/A 63034154

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R