BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50 TPR INSRT STD

    MDR report key: 7792468 · Received August 17, 2018

    Report

    Report Number
    3002806535-2018-00955
    Event Type
    Injury
    Date Received
    August 17, 2018
    Date of Event
    March 1, 2007
    Report Date
    May 3, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A HIP REVISION DUE TO EARLY INFECTION.

    Additional Manufacturer Narrative · 1

    (B)(4). UDI - (B)(4). CONCOMITANT PRODUCT(S): - BI-METRIC POROUS FMRL 10X130MM, ITEM 162252, LOT 1233569; THERAPY DATE -(B)(6) 2007. MEDICAL PRODUCT - M2A-MAGNUM MOD HD SZ 48MM , ITEM 157448, LOT 1212280; THERAPY DATE - (B)(6) 2007. MEDICAL PRODUCT - M2A-MAGNUM RECAP CUP 54ODX48ID, ITEM 157854, LOT 1213463; THERAPY DATE - (B)(6) 2007. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT 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. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2018- 00954,3002806535-2018-00956 AND 3002806535-2018-00957.

    Description of Event or Problem · 1

    INFORMATION RECEIVED UPON REVIEW OF JOURNAL ARTICLE ENTITLED "A RANDOMIZED SEVEN-YEAR STUDY ON PERFORMANCE OF THE STEMMED METAL M2A-MAGNUM AND CERAMIC C2A-TAPER, AND THE RESURFACING RECAP HIP IMPLANTS" BY SØREN RIBEL-MADSEN ET AL (2017). A B S T R A C T. BACKGROUND: THE LARGE-DIAMETER METAL-ON-METAL HIP PROSTHESES WERE EXPECTED TO HAVE LOW WEAR AND REDUCED DISLOCATION RATE COMPARED TO THE TRADITIONAL METAL-ON-POLYETHYLENE IMPLANTS. WE COMPARE 2 SUCH PROSTHESES, THE RECAP RESURFACING IMPLANT AND THE M2A-MAGNUM STEMMED IMPLANT, WITH THE C2A CERAMIC-ON-CERAMIC STEMMED IMPLANT AS TO CLINICAL PERFORMANCE, SERUM CONCENTRATIONS OF PROSTHESIS METALS, AND THE DURABILITY OF THE IMPLANTS IN A RANDOMIZED, CONTROLLED CLINICAL TRIAL AT 7 YEARS OF FOLLOW-UP. METHODS: ALL INCLUDED PATIENTS HAD OSTEOARTHRITIS. PREOPERATIVELY, THE SIZE OF THE IMPLANTS WAS ESTIMATED FROM A MAGNETIC RESONANCE IMAGING (MRI) SCAN. FOLLOW-UP DATA INCLUDED SERUM COBALT AND CHROMIUM CONCENTRATIONS, OXFORD AND HARRIS HIP SCORES, LEG PRESS AND ABDUCTION FORCE, 6-MINUTE WALK DISTANCE, WOMAC AND SF-36 SELF-ASSESSMENT SCORES, AND FROM THE 7TH POSTOPERATIVE YEAR ALSO ULTRASONOGRAPHY (US) EXAMINATION OF THE SOFT TISSUE ADJACENT TO THE IMPLANT AS WELL AS MRI WITH METAL ARTIFACT REDUCTION SEQUENCE (MARS-MRI) WHEN INDICATED. RESULTS: ONE HUNDRED FIFTY-TWO HIPS IN 146 PATIENTS WERE INCLUDED. THE SERUM COBALT AND CHROMIUM CONCENTRATIONS WERE SIGNIFICANTLY HIGHER FOR THE 2 METAL-ON-METAL PROSTHESES THAN FOR THE CERAMIC-ON-CERAMIC, WITH THE M2A-MAGNUM AS THE HIGHEST. NO SIGNIFICANT DIFFERENCE WAS FOUND BETWEEN THE GROUPS CONCERNING PHYSICAL PERFORMANCE MEASUREMENTS AND SCORES AS WELL AS DISLOCATIONS AND PROSTHESIS SURVIVAL. FIVE REVISIONS WERE DONE AND CONCERNED ALL GROUPS, FOR REASONS OF PAIN, HIGH SERUM COBALT AND CHROMIUM CONCENTRATIONS, CYSTIC FLUID COLLECTION AROUND THE JOINT, AND INFECTION. METAL CONCENTRATIONS, US, AND MARS-MRI CONTRIBUTED TO THE DECISION MAKING REGARDING PROSTHESIS REVISION. CONCLUSION: METAL CONCENTRATIONS WERE SIGNIFICANTLY HIGHER FOR THE METAL-ON-METAL PROSTHESES THAN FOR THE CERAMIC-ON-CERAMIC. THE CLINICAL PERFORMANCE WAS GOOD IN ALL 3 PROSTHESIS GROUPS. METAL CONCENTRATIONS, US, AND MARS-MRI FINDINGS WERE OF USE TO IDENTIFY HIPS NEEDING REVISION. THIS COMPLAINT REPORTS A PATIENT UNDERWENT HIP REVISION DUE TO EARLY INFECTION (PAGE 6, "DIAGNOSTICS OF IMPLANT FAILURES, AND REVISIONS DONE"). INFORMATION RECEIVED FROM CLINICAL STUDY DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634205 M2A-MAGNUM 42-50 TPR INSRT STD KWA BIOMET UK LTD. 1123394

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R