BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGE PF STD SANS CMT W/ HA T5

    MDR report key: 6990418 · Received October 31, 2017

    Report

    Report Number
    0009613350-2017-01513
    Event Type
    Injury
    Date Received
    October 31, 2017
    Date of Event
    October 4, 2017
    Report Date
    April 3, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWY
    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

    INVESTIGATION RESULTS WERE MADE AVAILABLE. CONCOMITANT MEDICAL PRODUCTS: SULOX HEAD, REF# 17.28.07, LOT#: 2114429 OR 2114430. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT WAS IDENTIFIED: FRACTURE OF THE STEM DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REVIEW OF EVENT DESCRIPTION: AFTER APPROXIMATELY 13 YEARS IN VIVO THE PF STEM WAS REVISED DUE TO A FRACTURE IN THE TRANSITION ZONE BETWEEN STEM NECK AND SHOULDER. REVIEW OF RECEIVED DATA: ¿MATERIAL VIGILANCE¿ DOCUMENT, DATED OCTOBER 12, 2017: A DOCUMENT REGARDING A MATERIAL VIGILANCE FROM THE HOSPITAL INFORMS THAT THE PATIENT HAD A CEMENTLESS PF STEM PROSTHESIS IMPLANTED IN 2003 ON THE LEFT HIP. THE PATIENT WAS HOSPITALIZED DUE TO A FRACTURE AT THE BASE OF THE NECK OF THE PROSTHESIS AND A REVISION OF THE STEM WAS MADE ON (B)(6) 2017. IT IS NOTED THAT A STATEMENT HAS BEEN SENT TO THE FRENCH COMPETENT AUTHORITIES). DEVICE ANALYSIS: VISUAL EXAMINATION: THE PF STEM SHOWS A FRACTURE IN THE TRANSITION ZONE BETWEEN STEM NECK AND SHOULDER. THE END OF THE RECTANGULAR IMPACTION HOLE IS SITUATED IN THIS AREA. THE FRACTURE SURFACES SHOW A FATIGUE FRACTURE. THE FRACTURE ORIGIN IS LOCATED ON THE POSTERIOR EDGE OF THE MEDIAL END OF THE IMPACTION HOLE. ON THE PROXIMAL FRACTURE SURFACE SEVERAL SMALL SPOT-LIKE DISCOLORATIONS AND SOME SCRATCHES CAN BE OBSERVED. THE DISTAL FRACTURE SURFACE SHOWS FEW SCRATCHES AND SOME POLISHED AREAS ON THE MEDIAL SIDE. ON THE INSIDE SURFACE OF THE IMPACTION HOLE, TOOL MARKS CAN BE OBSERVED ON BOTH FRACTURE PARTS OF THE STEM. PUTTING THE TWO FRACTURE PARTS TOGETHER, IT CAN BE OBSERVED THAT THESE MARKS ARE ALIGNED. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. CONCLUSION SUMMARY: AFTER APPROXIMATELY 13 YEARS IN VIVO THE PF STEM WAS REVISED DUE TO A FRACTURE IN THE TRANSITION ZONE BETWEEN STEM NECK AND SHOULDER. IN THIS REGION, A RECTANGULAR IMPACTION HOLE IS LOCATED. THE FRACTURE OCCURRED DUE TO FATIGUE AND ITS ORIGIN IS LOCATED AT THE POSTERIOR EDGE OF THE MEDIAL END OF THE IMPACTION HOLE. ON THE PROXIMAL FRACTURE SURFACE, THE LATERAL SURFACE OF THE STEM¿S NECK AND ON THE STEM¿S SHOULDER AREA THERE ARE SPOT-LIKE DISCOLORATIONS VISIBLE. THESE CAN PROBABLY BE ATTRIBUTED TO THE USE OF AN ELECTROSURGICAL INSTRUMENT (CAUTER) DURING SURGERY. A TOOL MARK WAS OBSERVED ON THE INSIDE OF THE RECTANGULAR IMPACTION HOLE ON BOTH FRACTURE PARTS OF THE STEM. AS THIS MARK IS MATCHING ON BOTH FRACTURE PARTS IT IS RATHER UNLIKELY THAT IT WAS MADE DURING REVISION SURGERY. HOWEVER, BASED ONLY ON THE RETRIEVALS INVESTIGATION AND WITHOUT ANY CLINICAL INFORMATION, IT STAYS UNKNOWN IF THIS DAMAGE WAS MADE BEFORE THE STEM FRACTURE AND IF IT HAD AN INFLUENCE ON IT. THE ELLIPTICAL SHAPED NOTCH ON THE LATERAL SIDE OF THE NECK OF THE STEM COULD POSSIBLY INDICATE AN IMPINGEMENT BETWEEN THE STEM AND CUP/INSERT. AS THE X-RAY FOLLOW-UP IS NOT AT HAND IT IS UNKNOWN IF THE POSITION OF THE IMPLANTS OR THE PATIENT¿S RANGE OF MOTION COULD HAVE LED TO THIS IMPINGEMENT SITUATION AND IF IT COULD HAVE HAD AN INFLUENCE ON THE FRACTURE. THE ORIGIN OF THE NOTCH ON THE MEDIAL SIDE OF THE STEM STAYS UNKNOWN. 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 (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE YET THE DEVICE, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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 WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A TIGE PF STD SANS CMT W/ HA T5 ON THE LEFT HIP IN 2003. THE PATIENT WAS REVISED ON (B)(6) 2017 DUE TO STEM BREAKAGE AT THE NECK JUNCTION. ON THE LETTER FROM HOSPITAL IT WAS REPORTED THAT THE PRODUCT WAS IMPLANTED IN 2003, BUT THE EXACT DATE IS UNKNOWN, WE ASSUME THEREFORE LAST DAY OF THE YEAR ((B)(6) 2003).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769449 TIGE PF STD SANS CMT W/ HA T5 UNKNOWN KWY ZIMMER GMBH N/A L0777

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R