BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP CEMENT FMRL HD RESUR44MM

    MDR report key: 7767209 · Received August 9, 2018

    Report

    Report Number
    3002806535-2018-00950
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    May 31, 2007
    Report Date
    May 2, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KXA
    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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENTA A LEFT HIP REVISION DUE TO FRACTURE OF COLLUM FEMORIS (NECK OF FEMUR) AND ADVERSE LOCAL TISSUE REACTION (ALTR).

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORT WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2018-0951. (B)(4). CONCOMITANT MEDICAL PRODUCT - M2A-MAGNUM RECAP CUP 50ODX44ID, ITEM 157850, LOT 1193386, THERAPY DATE - (B)(6) 2007. (B)(6). REPORT SOURCE: LITERATURE. ARNE BORGWARDT, , LOTTE BORGWARDT, , BO ZERAHN, HENRIK DAUGAARD, , LISE BORGWARDT, , SØREN RIBEL-MADSEN, ¿A RANDOMIZED SEVEN-YEAR STUDY ON PERFORMANCE OF THE STEMMED METAL M2A-MAGNUM AND CERAMIC C2A-TAPER, AND THE RESURFACING RECAP HIP IMPLANTS.¿ THE JOURNAL OF ARTHROPLASTY, 2017, DOI:10.1016/J.ARTH.2017.11.061. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BASED ON A 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 ARNE BORGWARDT, ET AL. (2017). ABSTRACT. 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. (B)(4) - "DIAGNOSTICS OF IMPLANT FAILURES, AND REVISIONS DONE" PAGE 6. IT WAS REPORTED ONE PATIENT UNDERWENT HIP REVISION DUE TO FRACTURE OF COLLUM FEMORIS (NECK OF FEMUR) AND ADVERSE LOCAL TISSUE REACTION (ALTR). ALTR HAD BEEN DIAGNOSED PRIOR TO FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608062 RECAP CEMENT FMRL HD RESUR44MM KXA BIOMET UK LTD. 928663

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R