BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GTS STANDARD FEMORAL STEM CEMENTLESS S-1

    MDR report key: 8810029 · Received July 21, 2019

    Report

    Report Number
    3006946279-2019-00336
    Event Type
    Injury
    Date Received
    July 21, 2019
    Report Date
    December 2, 2019
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    JDI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D11--MEDICAL PRODUCT: 36MM 12/14 TPR FEMORAL HEAD +8 NK; PART# 650-0890; LOT# 2868995, INVESTIGATED UNDER (B)(4). SHELL POROUS WITH MULTI HOLES 52 MM; PART# 00620205220; LOT 61653157 BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH; PART# 00625006530; LOT 62244032. BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH; PART# 00625006530; LOT 62239408. LINER 10 DEGREE ELEVATED RIM 3.5 MM OFFSET 36 MM I.D.; PART# 00631006236; LOT 61620245. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THEREFORE IT COULD NOT BE ANALYZED. NO X-RAYS, MEDICAL RECORDS, SURGICAL REPORT, PHOTOGRAPHS, LAB TEST WERE PROVIDED. THE REPORTED EVENT COULD NOT BE CONFIRMED. THE REVIEW OF THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT 8 PRODUCTS GTS STANDARD FEMORAL STEM SIZE -1, REFERENCE PS129GM1, LOT NUMBER 0000627954 WERE MANUFACTURED ON 2011, THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO NON CONFORMITY OR DEVIATION WAS OBSERVED WHICH COULD BE LINKED TO THE EVENT DESCRIBED IN THE COMPLAINT. REVIEW OF THE GTS STANDARD FEMORAL STEM SIZE-1 IFU WITH THE RESEARCH AND DEVELOPMENT DEPARTMENT SHOWED THAT THE GTS STEM PRODUCT IS NOT INDICATED FOR REVISION SURGERY. AFTER REVIEWING THE COMPLAINT WITH THE RESEARCH AND DEVELOPMENT DEPARTMENT, ORTHOPEDIC RESEARCH AND DEVELOPMENT MANAGER CONFIRMED THAT CURRENTLY THE IMPLANTED HEAD REFERENCE 650-0890 BATCH 2868995 WAS COMPATIBLE WITH THE GTS STANDARD FEMORAL STEM SIZE-1REFERENCE PS129GM1 BATCH 0000627954. HOWEVER, AT THE TIME OF THE REVISION SURGERY (IN MARCH 2013) ZIMMER AND BIOMET WERE SEPARATE COMPANIES AND THEREFORE IT WAS AN UNAUTHORIZED PRODUCT COMBINATION FOR WHICH NO COMPATIBILITY TESTING WAS UNDERTAKEN AND AS RESULT OF SUCH THERE WAS NO REGULATORY CLEARANCE. ADVICE FROM HEALTHCARE PROFESSIONAL WAS SEEKED TO KNOW IF, IN HIS OPINION, THE DEVELOPMENT OF A PSEUDO TUMOR OF 7 CM SIZE IS POSSIBLE IN 9 MONTHS, AND IF THE GTS STEM COULD BE THE CAUSE OF THE PSEUDOTUMOR. HOWEVER, WITH NO MEDICAL REPORTS, THE HEALTHCARE PROFESSIONAL COULD NOT GIVE A RELIABLE MEDICAL EXPERTISE TO ANSWER THE QUESTIONS. NO OTHER SIMILAR COMPLAINT HAS BEEN RECORDED REGARDING THIS EVENT FOR GTS STANDARD FEMORAL STEM SIZE -1, REFERENCE PS129GM1, LOT NUMBER 0000627954 WITHIN ONE YEAR. ACCORDING TO THE AVAILABLE DATA, THE EXACT ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. 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 · 0

    IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT AN INITIAL LEFT HIP REPLACEMENT SURGERY IN 2012, AFTER DIAGNOSIS OF A COXARTHROSIS. THE SURGERY CONSISTED OF THE IMPLANTATION OF A TOTAL HIP PROSTHESIS TYPE RESURFACING OF THE BIOMET BRAND. SUBSEQUENTLY, A BURSECTOMY AND SYNOVECTOMY WAS PERFORMED IN 2012 (REPORTED UNDER (B)(6). ON (B)(6) 2013, PROSTHETIC REPLACEMENT OCCURRED AS A RESULT OF THE SERIOUS PROBLEMS ARISING FROM THE FIRST PROSTHESIS (REPORTED UNDER (B)(6). DURING THE REVISION, A REVISION CUP WAS IMPLANTED OF TANTALUM TMT (ZIMMER) WITH A POLYETHYLENE CRISS-CROSSED METAL FRICTION TORQUE AND MINI STEM TYPE GTS (BIOMET). ALSO DURING 2013, IT HAS BEEN FURTHER REPORTED THAT THE PATIENT EXPERIENCED PAIN IN TROCHANTERIC AND THIGH AREA AND A 7 CM PSEUDOTUMOR WAS PRESENT ON MRI IMAGES (REPORTED UNDER (B)(4) FOR THE FEMORAL HEAD AND (B)(4) FOR THE GTS STEM). DURING 2015, A PREOPERATIVE STUDY SHOWS SIGNS OF LOOSENING OF THE GTS STEM. THE PATIENT WAS SCHEDULED FOR PROSTHETIC REPLACEMENT THAT OCCURRED AT THE START OF 2016, THROUGH THE IMPLANTATION OF A WAGNER STEM (REPORTED UNDER (B)(4) FOR THE GTS STEM LOOSENING). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENTS NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: 36MM 12/14 TPR FEMORAL HEAD +8 NK WITH PART# 650-0890, LOT# 2868995. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT HIP REPLACEMENT SURGERY IN 2012. SUBSEQUENTLY, A BURSECTOMY AND SYNOVECTOMY WERE PERFORMED IN 2012 . THE PATIENT WAS THEN REVISED ON (B)(6) 2013. DURING THE REVISION GTS STANDARD FEMORAL STEM CEMENTLESS S-1 WAS IMPLANTED. IT HAS BEEN FURTHER REPORTED THAT THE PATIENT EXPERIENCED PAIN IN TROCHANTERIC AND THIGH AREA AND A 7 CM PSEUDOTUMOR WAS PRESENT ON MRI IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603863 GTS STANDARD FEMORAL STEM CEMENTLESS S-1 HIP IMPLANT JDI BIOMET FRANCE S.A.R.L. N/A 0000627954

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention