BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER PERIARTICULAR DISTAL LATERAL FIBULAR PLATE

    MDR report key: 6123953 · Received November 23, 2016

    Report

    Report Number
    0001822565-2016-04337
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 17, 2016
    Report Date
    June 4, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRS
    PMA / PMN Number
    PK070906
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001822565-2017-01744).

    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, THE SCREW IS SEIZED INTO THE HOLE ON THE RETURNED PLATE. DIMENSIONS TAKEN ARE WITHIN SPECIFICATION. THE SCREW HEAD EXHIBITS TWO CRACKS AND CORROSION IS ON BOTH THE RETURNED SCREW AND THE RETURNED PLATE. ACCORDING TO SCANNING ELECTRON MICROSCOPY ANALYSIS: ENERGY-DISPERSIVE SPECTROSCOPY (EDS) ANALYSIS OF THE BASE MATERIAL OF THE BONE SCREW INDICATED THE ELEMENTS CONSISTENT WITH A STAINLESS STEEL ALLOY. EDS ANALYSIS OF THE BASE MATERIAL OF THE BONE PLATE INDICATED THE ELEMENTS CONSISTENT WITH A STAINLESS STEEL ALLOY. EDS ANALYSIS OF THE ¿BROWN SPECKS¿ INDICATED PRIMARILY THE ELEMENTS C, O, P, CA, MN, AND FE, WITH TRACE AMOUNTS OF NA, S, CL, K, CR, AND CO. 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. A TOTAL OF TWO (2) MEDWATCH REPORTS HAVE BEEN FILED REGARDING THIS EVENT; PLEASE ALSO REFERENCE 0001822565-2017-01744.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. AGE OR DATE OF BIRTH, WEIGHT, DATE IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE DEVICE HISTORY RECORDS FOR THE PRODUCT WERE REVIEWED AND IDENTIFIED NO DEVIATIONS OR ANOMALIES. THE PRODUCT WAS NOT RETURNED FOR REVIEW; THEREFORE THE EXACT CONDITION OF THE DEVICE IS UNKNOWN. THIS DEVICE IS USED FOR TREATMENT. A COMPLAINT HISTORY REVIEW WAS CONDUCTED FOR PART# 00235701704. THE SEARCH IDENTIFIED ZERO ADDITIONAL COMPLAINTS FOR THE SAME LOT#. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING REVISION OF A PERIARTICULAR PLATE, SPECKS OF BROWN DEBRIS COULD BE FOUND ON THE UPPER SIDE OF THE DEVICE, AS WELL AS MATERIAL DEBRIS ON THE BOTTOM SIDE OF THE DEVICE, WHICH CAUSED DIFFICULTY WITH REMOVAL. SIGNIFICANT CORROSION WAS ALSO NOTED AROUND THE SCREW-PLATE JUNCTION. INITIAL OPERATIVE NOTES INDICATED THAT THE X-RAYS TAKEN SHOWED GOOD POSITIONING.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING REVISION OF A PERIARTICULAR PLATE, SPECKS OF BROWN DEBRIS COULD BE FOUND ON THE UPPER SIDE OF THE DEVICE AS WELL AS MATERIAL DEBRIS ON THE BOTTOM SIDE OF THE DEVICE, WHICH CAUSED DIFFICULTY WITH REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776202 ZIMMER PERIARTICULAR DISTAL LATERAL FIBULAR PLATE TRAUMA IMPLANT HRS ZIMMER, INC. NA 63026957

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R