BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ECHO FFP STEM

    MDR report key: 4880072 · Received June 30, 2015

    Report

    Report Number
    0001825034-2015-02790
    Event Type
    Injury
    Date Received
    June 30, 2015
    Report Date
    November 6, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE JOURNAL ARTICLE.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO ADDRESS ONLY ONE EVENT OF THE ARTICLE. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/ UPDATED INFORMATION. EVENT OR PROBLEM, BRAND NAME, CATALOG AND LOT NUMBER, PATIENT AND DEVICE CODES, REPORT SOURCE, DEVICE EVALUATED BY MANUFACTURER, MANUFACTURER NARRATIVE. THE PRODUCT WAS NOT RETURNED FOR EVALUATION DUE TO UNKNOWN LOCATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD (DHR) AND COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT/ITEM NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION, UNDER POSSIBLE ADVERSE EFFECTS: ¿MATERIAL SENSITIVITY REACTIONS. IMPLANTATION OF FOREIGN MATERIAL IN TISSUES CAN RESULT IN HISTOLOGICAL REACTIONS INVOLVING VARIOUS SIZES OF MACROPHAGES AND FIBROBLASTS. THE CLINICAL SIGNIFICANCE OF THIS EFFECT IS UNCERTAIN, AS SIMILAR CHANGES MAY OCCUR AS A PRECURSOR TO OR DURING THE HEALING PROCESS." FOLLOWING REVIEW, NO NEW RISKS WERE IDENTIFIED. 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 (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "SHORT-TERM OUTCOMES AND TAPER REACTION OF THE SECOND GENERATION UNCEMENTED STEM IN TOTAL HIP ARTHROPLASTY" WHICH COMPARED THE SHORT-TERM OUTCOMES OF THE BIOMET MANUFACTURED ECHO BI-METRIC FULL PROXIMAL PROFILE (FPP) STEM AND ECHO REDUCED PROXIMAL PROFILE (RPP) STEM TO THEIR PREDECESSOR, THE BI-METRIC STEM. THE STUDY WAS CONDUCTED OVER A PERIOD OF TWENTY-EIGHT (28) YEARS (1986 TO 2014) AND INVOLVED ONE-THOUSAND TWO-HUNDRED SEVENTY-SEVEN (1277) ECHO FPP, THREE-HUNDRED SIXTY-SIX (366) ECHO RPP, AND ONE-THOUSAND FOUR-HUNDRED NINETY-SEVEN (1497) BI-METRIC STEMS. THE JOURNAL ARTICLE REPORTS THE FOLLOWING TAPER REACTIONS: FIFTY-ONE (51) ECHO FPP CASES OF DISTAL CORTICAL HYPERTROPHY, FIFTY-TWO (52) ECHO FPP CASES OF SPOT WELDING, FORTY-FIVE (45) ECHO RPP CASES OF DISTAL CORTICAL HYPERTROPHY, FORTY (40) ECHO RPP CASES OF SPOT WELDING, FIFTY-NINE (59) BI-METRIC CASES OF DISTAL CORTICAL HYPERTROPHY, SIXTY-SEVEN (67) BI-METRIC CASES OF SPOT WELDING. IN CONCLUSION, ALTHOUGH, THERE WAS NO STATISTICAL DIFFERENCE WITH THE SURVIVORSHIP, HARRIS HIP SCORE AND TAPER REACTION AMONG ECHO FPP, ECHO RPP AND BI-METRIC STEM, THE ECHO FPP AND ECHO RPP HAVE BEEN PERFORMING WELL WITH FEW TAPER REACTIONS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "SHORT-TERM OUTCOMES AND TAPER REACTION OF THE SECOND GENERATION UNCEMENTED STEM IN TOTAL HIP ARTHROPLASTY". THIS REPORT ADDRESSES, THE FIFTY-TWO (52) ECHO FPP STEMS THAT DEMONSTRATED SPOT WELDING POST THA PROCEDURE AT FOLLOW-UP OF MORE THAN THREE-YEARS. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421207 UNKNOWN ECHO FFP STEM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention