BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIMETRIC CEMENTLESS STEM

    MDR report key: 11392218 · Received March 1, 2021

    Report

    Report Number
    3002806535-2021-00067
    Event Type
    Injury
    Date Received
    March 1, 2021
    Report Date
    April 15, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE UK NJR NOTIFIED ZIMMER BIOMET ON 19 FEBRUARY 2021 THAT BIMETRIC CEMENTLESS STEM WAS IDENTIFIED AS A LEVEL 1 OUTLIER WHEN COMPARED TO OTHER CEMENTLESS STEMS IN THE UK NJR. AT THE TIME OF THE NOTIFICATION, THERE WERE 4,941 PRIMARY SURGERIES AND 406 REVISIONS (8.2 PERCENT RAW REVISION RATE, PTIR = 0.89). CURRENTLY, THERE ARE 4,946 BIMETRIC PRIMARY IMPLANTS AND 409 REVISIONS. SURVIVORSHIP IS 91.3 PERCENT AT 10 YEARS AND 87.8 PERCENT AT 15 YEARS. EXECUTIVE SUMMARY: BIMETRIC CEMENTLESS STEMS SHOW HIGHER REVISION RATES WHEN COMPARED TO OTHER SIMILAR STEMS IN THE UK NJR. IMPLANT SIZES, AND IN PARTICULAR, IMPLANT ARTICULATION, APPEAR TO BE RELATED TO THE HIGHER REVISION RATES. METAL HEADS HAD OVER A 3X HIGHER REVISION RATE THAN CERAMIC HEADS AND PATIENTS IMPLANTED FROM 2004-2008 HAD A HIGHER REVISION RATE THAN THOSE IMPLANTED FROM 2009 ON. THE PREDOMINANT REASON FOR REVISION WAS ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS¿ IN 217 OF THE 409 REVISED CASES (53.1 PERCENT). ZIMMER BIOMET INTERNAL ANALYSES OF UK NJR DATA. PATIENT DEMOGRAPHICS SHOW A HEALTHIER GROUP OF PATIENTS USING THE BIMETRIC CEMENTLESS STEM AS COMPARED TO OTHER CEMENTLESS STEMS. 28.9 PERCENT OF BIMETRIC CEMENTLESS STEM PATIENTS WERE ASA GRADE P1 WHEREAS ONLY 17.9 PERCENT OF ALL UK NJR CEMENTLESS PATIENTS WERE GRADE P1. AGE, BMI, GENDER AND INDICATIONS FOR USE WERE SIMILAR BETWEEN BIMETRIC CEMENTLESS STEM AND ALL OTHER CEMENTLESS STEMS IN THE UK NJR. NEXT, WE LOOKED AT MULTIPLE VARIABLES TO DETERMINE IF ANY WERE SIGNIFICANT IN PREDICTING THE HIGHER REVISION RATES. VARIABLES INCLUDED HEAD SIZE, HEAD AND CUP ARTICULATION, AND YEAR OF SURGERY. THERE WERE NUMEROUS HEAD SIZES USED, WITH SIGNIFICANTLY HIGHER REVISION RATES IN THE LARGER-SIZE HEADS, 38 MM HEADS AND LARGER. METAL CUP ARTICULATIONS WERE REVISED 15 PERCENT OF THE TIME. THE POLY AND CERAMIC CUPS WERE REVISED MUCH LESS (3.8 PERCENT AND 2.4 PERCENT, RESPECTIVELY). METAL HEADS ALSO HAD A SIGNIFICANTLY HIGHER REVISION RATE OVER CERAMIC HEADS (11.0 PERCENT VS 2.8 PERCENT). THE MAJORITY OF THE REVISIONS OCCURRED IN PATIENTS FROM 2004 ¿ 2008 WITH A COMBINED 14.4 PERCENT REVISION RATE. HOWEVER, FROM 2009 ON, THE REVISION RATE WAS 3.6 PERCENT. NEXT, REVISION RATES BY SITE WERE EXAMINED IN WHICH SITE 4283 IMPLANTED 1,554 DEVICES WITH 202 REVISIONS OR 13.0 PERCENT REVISION RATE ¿ WITH 134 REVISIONS FOR ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS. SITE 4314 IMPLANTED 254 WITH 11.4 PERCENT REVISION RATE AND SITE 4409 IMPLANTED 606 WITH A 7.8 PERCENT REVISION RATE. TWO SITES, 4188 AND 4514, HAD A DECENT SURVIVORSHIP, IMPLANTING 658 WITH A 3.0 PERCENT REVISION RATE AND 249 WITH A 1.6 PERCENT REVISION RATE, RESPECTIVELY. THE PREDOMINANT REASON FOR THE 409 REVISIONS FOR BIMETRIC CEMENTLESS STEM WAS ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS OCCURRING IN 217 CASES OR 53.1PERCENT OF ALL REVISIONS. BASED ON THE HIGHER REVISIONS SEEN WITH METAL CUP ARTICULATION AND METAL HEADS, METAL-ON-METAL (MOM) CUP ARTICULATION AND LINER CONFIGURATION VS OTHER CUP AND LINER COMBINATIONS WERE EVALUATED. MOM CONSTRUCT OUTCOMES DIFFER FROM OTHER CUP AND LINER COMBINATIONS. MOM CASES ACCOUNTED FOR 306 REVISIONS WHEREAS 100 WERE ATTRIBUTED TO NON-MOM CASES. THE 10-YEAR SURVIVAL ESTIMATE FOR MOM SYSTEMS IS 85.5 PERCENT AND THE 15 YEAR ESTIMATE IS 82 PERCENT. THE NON-MOM ESTIMATES ARE 96.3 PERCENT AND 93.4 PERCENT, RESPECTIVELY. THE PTIR FOR MOM IS APPRECIABLY HIGHER THAN NON-MOM, 1.41 COMPARED TO 0.41. METAL-ON-METAL IS A WELL-RESEARCHED HIP ARTICULATION AND ONCE MOM ARE REMOVED, BIMETRIC IS PERFORMING WITHIN EXPECTED LIMITS AS OTHER STEMS WHEN COMPARING BIMETRIC PTIR TO GROUP PTIR. BASED ON OUR ANALYSIS NO FURTHER ACTION IS NEEDED AND COMPLAINTS RECEIVED FOR THE BIMETRIC CEMENTLESS STEM WILL CONTINUE TO BE MONITORED AS PART OF OUR ONGOING PMS PROCESS.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO MAKE A CORRECTION. B5: THE COMPLAINT DESCRIPTION HAS BEEN CORRECTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    FOLLOWING A REVIEW OF THE DATA CONDUCTED IN SEPTEMBER 2020, THE NJR IDENTIFIED THAT THE FOLLOWING DEVICE APPEARS TO HAVE A PTIR INCLUDING CONFIDENCE INTERVALS TWICE THAT OF ITS DEVICE GROUP, AND AS SUCH THE NJR WILL BE REPORTING THIS TO THE MHRA. NJR IDENTIFIED 406 REVISIONS FOR THE BIMETRIC CEMENTLESS STEM. THIS COMPLAINT REPORTS THE 406 REVISIONS FOR THE BIMETRIC CEMENTLESS STEM DUE TO UNKNOWN REASONS.

    Description of Event or Problem · 0

    FOLLOWING A REVIEW OF THE DATA CONDUCTED IN SEPTEMBER 2020, THE NJR IDENTIFIED THAT THE FOLLOWING DEVICE APPEARS TO HAVE A PTIR INCLUDING CONFIDENCE INTERVALS TWICE THAT OF ITS DEVICE GROUP, AND AS SUCH THE NJR WILL BE REPORTING THIS TO THE MHRA. NJR IDENTIFIED 406 REVISIONS FOR THE BIMETRIC CEMENTLESS STEM. THIS COMPLAINT REPORTS THE 406 REVISIONS FOR THE BIMETRIC CEMENTLESS STEM DUE TO UNKNOWN REASONS.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION (PRODUCT LOCATION IS UNKNOWN). POSTAL CODE: (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A REVIEW OF THE DATA CONDUCTED IN SEPTEMBER 2020, THE (B)(6) REGISTRY ((B)(6)) IDENTIFIED THAT THE ROTATING HINGE KNEE (RHK) WITHOUT PRIMARY PATELLA RESURFACING APPEARS TO HAVE A PATIENT TIME INCIDENCE RATE (PTIR) INCLUDING CONFIDENCE INTERVALS TWICE THAT OF ITS DEVICE GROUP. (B)(6) IDENTIFIED 406 REVISIONS FOR THE BIMETRIC CEMENTLESS STEM. THIS COMPLAINT REPORTS THE 406 REVISIONS FOR THE BIMETRIC CEMENTLESS STEM DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288855 UNKNOWN BIMETRIC CEMENTLESS STEM UNKNOWN KNEE ARTROPLASTY NRA BIOMET UK LTD. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R