BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK RECAP MAGNUM

    MDR report key: 9415565 · Received December 5, 2019

    Report

    Report Number
    3002806535-2019-00906
    Event Type
    Injury
    Date Received
    December 5, 2019
    Report Date
    April 17, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-009005-1. THE INFORMATION RECEIVED FROM NATIONAL JOINT REGISTRY (NJR) REPORTED THAT ONE HUNDRED AND SIXTY-FOUR PATIENTS WITH TAPERLOC 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 PTIRS. THE DIFFERENCE WAS NOT SIGNIFICANT ENOUGH TO TRIGGER ANY MAJOR ACTION BY THE COMMITTEE. A RESPONSE HAS BEEN SENT TO THE NJR STATING THAT ANALYSIS OF THE DATA ASSOCIATED WITH THE REVISIONS FOUND THAT PATIENT DEMOGRAPHICS SHOW A SIMILAR PROPORTION OF ASA GRADES AND PERCENTAGE OF PATIENTS TREATED FOR OSTEOARTHRITIS WHEN TAPERLOC CEMENTLESS STEM AND RECAP MAGNUM IS COMPARED TO SIMILAR HIP SYSTEMS IN THE UK NJR. IN ADDITION, OTHER VARIABLES WERE ASSESSED TO DETERMINE IF ANY WERE SIGNIFICANT IN PREDICTING THE HIGHER REVISION RATES. VARIABLES INCLUDED HEAD SIZE, HEAD AND CUP ARTICULATION, INDICATION AND YEAR OF SURGERY. NONE OF THESE VARIABLES SHOWED A CLEAR TREND. THE SURGERIES FOR THIS HIP SYSTEM OCCURRED FROM 2005-2012, WITH THE HIGHEST NUMBER IMPLANTED IN 2009, FOLLOWED BY 2008. ONLY 18 OF THE 164 REVISIONS OCCURRED WITHIN ONE YEAR AFTER SURGERY. ADVERSE SOFT TISSUE REACTION WAS REPORTED AS A REASON FOR REVISION IN 77 OUT OF THE 164 REVISIONS (46.7 PERCENT). 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 TAPERLOC CEMENTLESS STEMS AND RECAP MAGNUM WILL CONTINUE TO BE MONITORED AS PART OF OUR ONGOING PMS PROCESS. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY H3 OTHER TEXT : PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 164 PATIENTS UNDERWENT PRIMARY HIP REPLACEMENT. SUBSEQUENTLY, 164 REVISION IDENTIFIED BY NJR FOR THE TAPERLOC CEMENTLESS STEM/ RECAP MAGNUM. REVISIONS WERE PERFORMED FOR UNKNOWN REASONS ON AN UNKNOWN DATE. INSPECTION OF THE DATA CONDUCTED IN MARCH 2019, SHOWS THAT CALCULATED PTIR (REVISION RATE PER ONE HUNDRED PATIENT YEARS OF IMPLANTATION) OF ALL DEVICES IS ABOVE THE AVERAGE FOR ITS GROUP PTIR¿S. 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 US OF THEIR FINDINGS, IN ORDER THAT WE CAN INVESTIGATE FURTHER AND CONSIDER WHETHER ANY CORRECTIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: UNK TAPERLOC CEMENTLESS STEM CATALOG #: NOT REPORTED LOT #: NOT REPORTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00905. 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 164 TAPERLOC CEMENTLESS STEM REVISIONS OCCURRED DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210781 UNK RECAP MAGNUM HIP PROSTHESIS KWA BIOMET UK LTD. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R