BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECOFIT® HIP STEM 133° CEMENTLESS LATERALIZED CPTI 15 MM

    MDR report key: 21420917 · Received February 20, 2025

    Report

    Report Number
    3012523063-2025-00022
    Event Type
    Injury
    Date Received
    February 20, 2025
    Date of Event
    January 22, 2025
    Report Date
    April 23, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    LZO
    PMA / PMN Number
    K163577
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO THE IMPLANTCAST GMBH THAT AN ECOFIT® HIP STEM 133° CEMENTLESS LATERALIZED CPTI 15 MM HAD TO BE REVISED AFTER AN IMPLANTATION PERIOD OF 4 YEARS AND 11 MONTHS DUE TO LOOSENING. PROVIDED X-RAY IMAGES AND AN EXTERNAL MEDICAL REPORT CONFIRM THE PRESENCE OF A LYSIS SEAM AROUND THE METAPHYSIS OF THE HIP STEM. IT IS POSSIBLE THAT SCLEROSIS OF THE BONE HAS CONTRIBUTED TO THE LOOSENING, AS IT MIGHT HAD A NEGATIVE IMPACT ON THE BONE INGROWTH. HOWEVER, NO CONFIRMED EVIDENCE IS GIVEN AND FURTHER X-RAYS IMMEDIATELY AFTER IMPLANTATION AND FOLLOWING THE PATIENTS PROGRESS WOULD BE REQUIRED TO MAKE AN ACCURATE ASSESSMENT. OPTICAL EXAMINATION OF THE EXPLANT WAS NOT POSSIBLE, AS IT WAS NOT PROVIDED TO THE IMPLANTCAST GMBH. THE MANUFACTURING DOCUMENTS AND DESCRIPTION OF THE SURGICAL TECHNIQUE WERE CHECKED, NO DEVIATIONS WERE FOUND. THE INSTRUCTION FOR USE EXPLAINS THAT THE DURABILITY OF AN IMPLANT CAN BE LIMITED BY BIOLOGICAL, MATERIAL, AND BIOMECHANICAL FACTORS. AS THE PATIENT IS OVERWEIGHT (BMI 27.5 KG/M2), THIS MAY HAS CAUSED AN INCREASED LOAD ON THE JOINT. AN EARLY LOOSENING OF THE IMPLANT MIGHT BE A POSSIBLE CONSEQUENCE. THE SURGICAL REPORTS PROVIDED GIVE NO FURTHER INDICATION OF POTENTIAL CAUSES FOR THE FAILURE OF THE IMPLANT. IN CONCLUSION, THE AVAILABLE DATA ARE NOT SUFFICIENT TO IDENTIFY THE ROOT CAUSE OF THE INCIDENT, BUT PATIENT SPECIFIC FACTORS (OVERWEIGHT, SCLEROSIS) MAY HAVE CONTRIBUTED. THE INCIDENT WAS ASSIGNED TO THE ERROR PATTERN "ASEPTIC LOOSENING" IN THE ASSOCIATED RISK MANAGEMENT.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO THE IMPLANTCAST GMBH THAT AN ECOFIT® HIP STEM 133° CEMENTLESS LATERALIZED CPTI 15 MM HAD TO BE REVISED AFTER AN IMPLANTATION PERIOD OF 4 YEARS AND 11 MONTHS DUE TO LOOSENING. PROVIDED X-RAY IMAGES AND AN EXTERNAL MEDICAL REPORT CONFIRM THE PRESENCE OF A LYSIS SEAM AROUND THE METAPHYSIS OF THE HIP STEM. IN ADDITION, IT IS NOTED THAT THE STEM HAS BEEN CHOSEN IN A TOO SMALL SIZE, AS IT IS NOT WELL FIXED/ PRESSED INTO THE BONE AFTER IMPLANTATION. CONSEQUENTLY, AN EARLY SUBSIDENCE OF THE STEM OCCURRED. THE LACK OF PROSTHESIS FIXATION CAUSED A STRESS REACTION IN THE BONE, RESULTING IN DENSIFICATION AND THICKENING OF THE BONE AROUND THE TIP OF THE STEM. HOWEVER, THIS DID NOT PREVENT FURTHER LOOSENING. OPTICAL EXAMINATION OF THE EXPLANT WAS NOT POSSIBLE, AS IT WAS NOT PROVIDED TO THE IMPLANTCAST GMBH. THE MANUFACTURING DOCUMENTS AND DESCRIPTION OF THE SURGICAL TECHNIQUE WERE CHECKED, NO DEVIATIONS WERE FOUND. THE INSTRUCTION FOR USE EXPLAINS THAT THE DURABILITY OF AN IMPLANT CAN BE LIMITED BY BIOLOGICAL, MATERIAL, AND BIOMECHANICAL FACTORS. AS THE PATIENT IS OVERWEIGHT (BMI 27.5 KG/M2), THIS MAY HAS CAUSED AN INCREASED LOAD ON THE JOINT. AN EARLY LOOSENING OF THE IMPLANT MIGHT BE A POSSIBLE CONSEQUENCE. THE SURGICAL REPORTS PROVIDED INDICATE STRONG SCLEROSIS OF THE DISTAL FEMUR. HOWEVER, THE PRESENCE OF SCLEROTIC BONE IS NOT A GENERAL CONTRAINDICATION TO THE USE OF A CEMENTLESS PROSTHESIS SYSTEM, AS STATED IN AN EXTERNAL EXPERT REPORT. NO FURTHER INFORMATION IS PROVIDED ON POTENTIAL CAUSES OF IMPLANT FAILURE. IN CONCLUSION, THE AVAILABLE DATA INDICATE THAT THE INCIDENT IS NOT CAUSED BY A DEFECTIVE PRODUCT, BUT BY A WRONG STEM SIZE SELECTION BY THE THREATING PHYSICIAN. PATIENT SPECIFIC FACTORS (OVERWEIGHT, SCLEROSIS) MAY HAVE CONTRIBUTED. THE INCIDENT WAS ASSIGNED TO THE ERROR PATTERN "ASEPTIC LOOSENING" IN THE ASSOCIATED RISK MANAGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "DUE TO THE PATIENT'S INCREASING DISCOMFORT, AN X-RAY WAS TAKEN. THIS REVEALED AN INCREASING LYSIS SEAM IN THE AREA OF THE METAPHYSIS AROUND THE PROSTHESIS STEM. THE INDICATION FOR STEM REVISION WAS GIVEN. "

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "DUE TO THE PATIENT'S INCREASING DISCOMFORT, AN X-RAY WAS TAKEN. THIS REVEALED AN INCREASING LYSIS SEAM IN THE AREA OF THE METAPHYSIS AROUND THE PROSTHESIS STEM. THE INDICATION FOR STEM REVISION WAS GIVEN. " ON (B)(6) 2025 A PRE-REVISION X-RAY OF BETTER QUALITY AND ADDITIONAL X-RAYS AFTER THE IMPLANTATION AND FROM THE FOLLOW-UP WERE ANALYSED BY AN EXTERNAL EXPERT AND PROVIDED THE IMPLANTCAST GMBH WITH ADDITIONAL INFORMATION, SO THAT A FOLLOW UP INVESTIGATION WAS STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038030 ECOFIT® HIP STEM 133° CEMENTLESS LATERALIZED CPTI 15 MM HIP STEM LZO IMPLANTCAST GMBH 30374150

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention ECOFIT® CUP EPORE® CEMENTLESS Ø 56 MM REF (B)(4) | ECOFIT® CUP EPORE® CEMENTLESS Ø 56 MM REF (B)(4). | IC-HEAD BIOLOX®DELTA TAPER 12/14 Ø36S REF (B)(4). | IC-HEAD BIOLOX®DELTA TAPER 12/14 Ø36S REF (B)(4). | PE INSERT 0°Ø 36/48 MM REF (B)(4) | PE INSERT 0°Ø 36/48 MM REF (B)(4).