BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL, ALPHA INSERT, JJ/32

    MDR report key: 7432505 · Received April 16, 2018

    Report

    Report Number
    0009613350-2018-00446
    Event Type
    Injury
    Date Received
    April 16, 2018
    Date of Event
    September 12, 2017
    Report Date
    August 8, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITTANT MEDICAL DEVICE: - ALLOFIT ALLOCLASSIC SHL 54/JJ, REF#04246, LOT#:UNKNOWN THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: - 0009613350-2018-00447 - 0009613350-2018-00446 TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: REVISION SURGERY DUE TO OSTELOYSIS. DEVICE HISTORY RECORDS (DHR): ALLOCLASSIC CUP: AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE LOT NUMBER WAS NOT LEGIBLE ON THE RETURNED PRODUCT. AT ZIMMER GMBH ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION- AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER GMBH AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR. ALPHA INSERT: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REVIEW OF EVENT DESCRIPTION: THE ALLOFIT® ALLOCLASSIC® SHELL AND THE METASUL® ALPHA INSERT WERE REVISED AFTER APPROXIMATELY 10 YEARS AND 7 MONTHS IN VIVO DUE TO OSTEOLYSIS OBSERVED BEHIND THE CUP. REVIEW OF RECEIVED DATA: THE FOLLOWING WAS REPORTED: ¿PRIMARY SURGERY WAS PERFORMED ON 15 FEBRUARY 2007 AT WANGARATTA PRIVATE HOSPITAL BY DR MICHAEL FALKENBERG. REVISION SURGERY DATE IS 12 SEPTEMBER 2017 AND SURGEON IS DR CHRIS JONES AT CABRINI HOSPITAL. PATIENT WAS REVISED DUE TO LYSIS BEHIND THE CUP. SEE X-RAY ATTACHED. NO FURTHER INFORMATION IS AVAILABLE. ¿ - X-RAYS ONE UNDATED X-RAY WAS RECEIVED FOR REVIEW. THE X-RAY WAS RECEIVED IN A RATHER BAD QUALITY WITH SOME LIGHT REFLECTIONS. AS THE X-RAY IS REFERRED IN THE REPORTED EVENT, IT IS ASSUMED THAT THE X-RAY WAS TAKEN SHORTLY BEFORE THE REVISION SURGERY. THERE SEEMS TO BE SOME RADIOLUCENT AREAS BEHIND THE CUP. HOWEVER WITH NO DATE AND NO OTHER X-RAYS TO COMPARE, IT REMAINS UNKNOWN IF THESE EXISTED FROM THE BEGINNING OR DEVELOPED OVER TIME. DEVICES ANALYSIS: - VISUAL EXAMINATION THE METASUL® ALPHA INSERT AND THE ALLOFIT® ALLOCLASSIC® SHELL ARE STILL ASSEMBLED. THE INSERT AND THE SHELL SHOW SLIGHT DAMAGE FROM REVISION SURGERY IN THE FORM OF CUTS, SCRATCHES AND DENTS. THE INSERT IS FIRMLY FIXED IN THE SHELL. REMOVAL OF THE INSERT FROM THE SHELL WAS NOT CARRIED OUT AS IT PROBABLY WOULD HAVE DAMAGED THE COMPONENTS. ON THE ARTICULATION SURFACE, NUMEROUS FINE SCRATCHES, SOME COARSE SCRATCHES AND SOME ELECTROSURGICAL DAMAGE CAN BE SEEN. THE RIM OF POLYETHYLENE EXHIBITS SOME SLIGHT SCRATCHES AND DAMAGE WHICH MOST LIKELY DERIVED FROM THE REVISION SURGERY. THE POLYETHYLENE SEEMS TO BE SLIGHTLY YELLOWISH DISCOLORED. IN ONE LOCATION, THE POLYETHYLENE RIM AND THE EDGE OF THE SHELL ARE DAMAGED WHICH DERIVED FROM THE REVISION SURGERY. ON THE ANCHORING SIDE OF THE SHELL REMAINS OF BONE ATTACHMENTS CAN BE OBSERVED. THE LARGER PIECES OF THE BONE ATTACHMENT SHOW A CLEAN CUT SURFACE. SOME OF THE TIPS OF THE MACROSTRUCTURE ARE SLIGHTLY DEFORMED AND HAVE A SHINY APPEARANCE. BOTH MOST LIKELY DERIVED FROM A REMOVAL INSTRUMENT DURING THE REVISION SURGERY. CONCLUSION SUMMARY: THE ALLOFIT® ALLOCLASSIC® SHELL AND THE METASUL® ALPHA INSERT WERE REVISED AFTER APPROXIMATELY 10 YEARS AND 7 MONTHS IN VIVO DUE TO OSTEOLYSIS OBSERVED BEHIND THE CUP. THE RECEIVED COMPONENTS ARE INCONSPICUOUS. NO CLINICAL INFORMATION, ESPECIALLY REGARDING THE REVISION SURGERY, AND NO X-RAY FOLLOW-UP WERE AVAILABLE. THEREFORE, ON THE BASIS OF RETRIEVAL INVESTIGATION AND THE RECEIVED INFORMATION THE REASONS FOR THE REPORTED OSTEOLYSIS OBSERVED BEHIND THE CUP CANNOT BE EXPLAINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS CMP-0329765.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K013935. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO ACETABULAR OSTEOLYSIS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275463 METASUL, ALPHA INSERT, JJ/32 KWA ZIMMER GMBH N/A 2357717

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ALLOCLASSIC CUP, ITEM# UNKNOWN, LOT# UNKNOWN| ALLOCLASSIC CUP, ITEM# UNKNOWN, LOT# UNKNOWN