BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL, ALPHA INSERT, GG/28

    MDR report key: 7312682 · Received March 5, 2018

    Report

    Report Number
    0009613350-2018-00318
    Event Type
    Injury
    Date Received
    March 5, 2018
    Date of Event
    January 1, 2012
    Report Date
    September 11, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: DISLOCATION. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE INFORMATION WAS REQUESTED AT COMPLAINANT, HOWEVER IT IS CURRENTLY NOT AVAILABLE. 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. EVENT DESCRIPTION (EVENT DETAILS, PER) - EVENT SUMMARY: IT IS REPORTED THAT A PATIENT WHO IS PARTICIPATING IN A CLINICAL STUDY EXPERIENCED DISLOCATION OF HEAD AND LINER AROUND 5 YEARS POST IMPLANTATION. IT WAS ALSO REPORTED THAT THIS PATIENT HAD THE DISLOCATION BECAUSE HE WAS FALLING. A CLOSED REDUCTION UNDER GENERAL ANAESTHESIA WAS PERFORMED AND PATIENT UNDERWENT FOR PHYSIOTHERAPY AFTERWARDS. HOWEVER, THE PATIENT STAYED IN THE STUDY AND COMPLETED HIS FOLLOW-UP VISITS UNTIL THE END (I.E. 10 YEARS). HIS LAST FOLLOW-UP VISIT WAS IN (B)(6) 2017. REVIEW OF RECEIVED DATA NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS; THE DEVICES ARE STILL IN VIVO. REVIEW OF PRODUCT DOCUMENTATION - THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS ROOT CAUSE DETERMINATION USING RMW (FOR METASUL INSERT): - LOSS OF INSERT-SHELL CONNECTION, COMPONENT LOOSENING, DISLOCATION DUE TO INSUFFICIENT INSERT STABILITY DUE TO DESIGN (SNAP GEOMETRY) NOT POSSIBLE A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - IMPLANT DISLOCATION / LOOSENING / FRACTURE DUE TO SELECTION OF WRONG COMPONENTS NOT POSSIBLE THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. THEREFORE THIS CAUSE CAN BE EXCLUDED. - INCOMPLETE INSERT FIXATION IN SHELL LEADING TO POSTOP COMPLICATIONS (INSERT DISLOCATION, LOOSENING, FRACTURE DUE TO WRONG OR INCOMPLETE INSPECTION POSSIBLE, NO DATA/INFO (E.G. SURGICAL REPORT OF IMPLANTATION) WERE RECEIVED FOR EVALUATION OF IMPLANTING SCENARIO. THEREFORE THIS CAUSE CANNOT BE EXCLUDED CONCLUSION SUMMARY IT IS REPORTED THAT A PATIENT WHO IS PARTICIPANT OF A CLINICAL STUDY EXPERIENCED 5 YEARS POST-OP WHILE HE WAS FALLING A HIP DISLOCATION. PATIENT WAS TREATED WITH CLOSE REDUCTION AND PHYSIO THERAPY AFTERWARDS. AN EXACT ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION AT HAND. SEVERAL FACTORS, BESIDE PATIENT¿S FALL, SUCH AS E.G. MALPOSITION OF COMPONENTS, TISSUE IMPINGEMENT, SOFT TISSUE LAXITY COULD CONTRIBUTE TO REPORTED DISLOCATION. HOWEVER, ALL POSSIBLE CAUSES RELATED TO THE ISSUES REPORTED ARE LISTED IN THE APPROPRIATE RISK MANAGEMENT WORKSHEET OF THE DEVICES. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER BIOMET CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT THE PATIENT HAD A DISLOCATION BECAUSE OF A FALL. THE PATIENT HAD A REDUCTION OF THIS DISLOCATION UNDER GENERAL ANESTHESIA.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: METASUL HEAD 28 MM "M" 12/14, REF# 19.28.06, LOT # UNKNOWN, ALLOFIT ALLOCLASSIC SHL 48/GG, REF# 4243, LOT# UNKNOWN, AVENIR MÜLLER, STEM, LATERAL, UNCEMENTED, HA, 2, TAPER 12/14, REF# 01.06010.102, LOT# UNKNOWN. THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2018-00317. THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E DURASUL ALPHA EINSATZ NEUTRAL Ø GG/32) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. THE MANUFACTURER DID NOT RECEIVE THE DEVICES FOR REVIEW AS THEY ARE STILL IMPLANTED. X-RAYS OR OTHER SOURCE DOCUMENTS WERE NOT PROVIDED FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON MARCH 1, 2018 TO THE RESPONSIBLE PERSON WHO INITIATED THIS COMPLAINT: LOT NUMBER OF THE IMPLANTS, ALL AVAILABLE X-RAYS DURING TIME IN- VIVO WITH PRINTED DATE, ALL AVAILABLE INTRAOPERATIVE PICTURES, PATIENT¿S RELEVANT HISTORY, WERE THERE ANY CONTRIBUTING CONDITIONS RELATED TO THE EVENT? (EX: TRAUMA, ILLNESS, PREVIOUS SURGERY, RELATED NON-COMPLIANCE, PATIENT ANATOMY). A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A THA AND EXPERIENCED A PROSTHETIC DISLOCATION AFTER APPROX. 5 YEARS IN VIVO. PATIENT UNDERWENT PRESCRIBED PHYSIOTHERAPY. THE DEVICES WERE NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157450 METASUL, ALPHA INSERT, GG/28 N/A LPH ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention