BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BIMETRIC CEMENTLESS STEM

    MDR report key: 9415086 · Received December 5, 2019

    Report

    Report Number
    3002806535-2019-00903
    Event Type
    Injury
    Date Received
    December 5, 2019
    Report Date
    July 2, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORT SOURCE, FOREIGN: EVENT OCCURRED IN UNITED KINGDOM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00904-2. THE INFORMATION RECEIVED FROM NATIONAL JOINT REGISTRY (NJR) REPORTED THAT 67 PATIENTS WITH BIMETRIC CEMENTLESS STEM / RECAP MAGNUM IMPLANTS WERE REVISED DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION IS AVAILABLE FROM THE NJR. THE NJR INDICATED THAT INSPECTION OF THE DATA SHOWS THAT THE CALCULATED PTIR (REVISION RATE PER ONE HUNDRED PATIENT YEARS OF IMPLANTATION) OF ALL DEVICES IS ABOVE THE AVERAGE FOR ITS GROUP PTIR. THE DIFFERENCE WAS NOT SIGNIFICANT ENOUGH TO TRIGGER ANY MAJOR ACTION BY THE COMMITTEE. HOWEVER, THESE NUMBERS DO GIVE CAUSE FOR CONCERN, HENCE NJR DECIDED TO INFORM ZIMMER BIOMET OF THEIR FINDINGS, IN ORDER THAT WE CAN INVESTIGATE FURTHER AND CONSIDER WHETHER ANY CORRECTIVE ACTIONS ARE REQUIRED. ZIMMER BIOMET INTERNAL ANALYSES OF UK NJR BIMETRIC CEMENTLESS STEM / RECAP MAGNUM DATA: EXECUTIVE SUMMARY: BIMETRIC CEMENTLESS STEM AND RECAP MAGNUM SHOWS HIGHER REVISION RATES WHEN COMPARED TO OTHER SIMILAR STEM COMBINATIONS IN THE UK NJR. THIS DEVICE COMBINATION WAS LAST IMPLANTED IN 2011. THIS IS A METAL-ON-METAL SYSTEM AND 40 OF THE 68 REVISIONS (58.8%) WERE DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS. BACKGROUND: THE NATIONAL JOINT REGISTRY NOTIFIED ZIMMER BIOMET ON 13 NOVEMBER 2019 THAT BIMETRIC CEMENTLESS STEM AND RECAP MAGNUM WERE IDENTIFIED AS A LEVEL 2 OUTLIER WHEN COMPARED TO OTHER CEMENTLESS STEM COMBINATIONS IN THE UK NJR. AT THE TIME OF THE NOTIFICATION, THERE WERE 666 PRIMARIES AND 67 REVISIONS (10.1% RAW REVISION RATE, PTIR = 1.00). CURRENTLY, THERE ARE 666 PRIMARIES IMPLANTED AND 68 REVISIONS. SURVIVORSHIP IS 89.9% AT 10 YEARS AND 88.3% AT 14 YEARS. ZIMMER BIOMET INTERNAL ANALYSIS: PATIENT DEMOGRAPHICS SHOW A HEALTHIER GROUP OF PATIENTS USING BIMETRIC CEMENTLESS STEM AND RECAP MAGNUM AS COMPARED TO OTHER CEMENTLESS STEM COMBINATIONS. 29.3% OF BIMETRIC CEMENTLESS STEM AND RECAP MAGNUM PATIENTS WERE ASA GRADE P1, WHEREAS ONLY 18.3% OF ALL UK NJR CEMENTLESS PATIENTS WERE ASA GRADE P1. AGE DEMOGRAPHICS AND INDICATIONS FOR USE WERE SIMILAR BETWEEN BIMETRIC CEMENTLESS STEM AND ALL OTHER CEMENTLESS STEMS IN THE UK NJR. NEXT, WE LOOKED AT OTHER 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 WAS NO SIGNIFICANCE IN HEAD SIZES USED. THE HEADS IMPLANTED WERE ALL METAL HEADS AND IN THIS COMBINATION, WERE USED WITH RESURFACING CUPS. THE MAJORITY OF THE REVISIONS OCCURRED IN PATIENTS FROM 2005 ¿ 2008. 2011 WAS THE LAST YEAR THIS COMBINATION WAS IMPLANTED IN THE UK. THE NUMBER ONE REASON FOR THE 68 REVISIONS WAS ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS, OCCURRING IN 40 OF THE 68 REVISIONS OR 58.8% OF ALL REVISIONS. METAL-ON-METAL IS A WELL-RESEARCHED HIP ARTICULATION. RECAP MAGNUM IS NO LONGER IMPLANTED IN THE UK NJR. BASED ON OUR ANALYSIS NO FURTHER ACTION IS NEEDED AND COMPLAINTS RECEIVED FOR BIMETRIC CEMENTLESS STEM AND RECAP MAGNUM WILL CONTINUE TO BE MONITORED AS PART OF OUR ONGOING PMS PROCESS RISK ASSESSMENT: WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT AND WITHOUT ADEQUATE INFORMATION RECEIVED REGARDING THE EVENT, ROOT CAUSE COULD NOT BE DETERMINED AND THEREFORE RISK COULD NOT BE ASSESSED AGAINST OCCURRENCE OR ANY NEW PREVIOUSLY UNIDENTIFIED RISK. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. 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. PRODUCT HAS NOT BEEN RETURNED.

    Additional Manufacturer Narrative · 0

    (B)(4). G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN UNITED KINGDOM. D11: MEDICAL PRODUCT: UNKNOWN RECAP MAGNUM, CATALOG #: UNKNOWN, LOT #: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00904-1. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. THE ITEM NUMBER AND LOT NUMBER IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY AND THE COMPLAINT HISTORY WAS NOT PROVIDED. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT AND WITHOUT ADEQUATE INFORMATION RECEIVED REGARDING THE EVENT, ROOT CAUSE COULD NOT BE DETERMINED AND THEREFORE RISK COULD NOT BE ASSESSED AGAINST OCCURRENCE OR ANY NEW PREVIOUSLY UNIDENTIFIED RISK. CORRECTIVE ACTION TAKEN: NO CORRECTIVE ACTION REQUIRED AT THIS TIME. PREVENTIVE ACTION TAKEN: NO PREVENTIVE ACTION REQUIRED AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    THE INFORMATION RECEIVED FROM NATIONAL JOINT REGISTRY (NJR) REPORTED THAT 67 PATIENTS WITH BIMETRIC CEMENTLESS STEM / RECAP MAGNUM IMPLANTS WERE REVISED DUE TO UNKNOWN REASONS. PATIENT TIME INCIDENCE RATE (PTIR) : 1.00; GROUP PTIR : 0.43. NO FURTHER INFORMATION IS AVAILABLE FROM THE NJR.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE NATIONAL JOINT REGISTRY THAT 67 BIMETRIC CEMENTLESS STEM REVISIONS OCCURRED DUE TO UNKNOWN REASONS.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: UNK RECAP MAGNUM CATALOG #: NOT REPORTED LOT #: NOT REPORTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00904. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE NATIONAL JOINT REGISTRY THAT 67 BIMETRIC CEMENTLESS STEM REVISIONS OCCURRED DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210305 UNK BIMETRIC CEMENTLESS STEM HIP PROSTHESIS JDI BIOMET UK LTD. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10