BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLS® SPOTORNO®, STEM, 135°, UNCEMENTED, 9.0, TAPER 12/14

    MDR report key: 21841613 · Received April 15, 2025

    Report

    Report Number
    0009613350-2025-00311
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    October 20, 2015
    Report Date
    September 23, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. ARTEK CUP ME 38/50 ITEM# 91363850 LOT# 2063721. METASUL-FEMORAL HEAD 38 M ITEM# 193806 LOT# 2089138. G2. REPORT SOURCE: GERMANY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H10, H11. CORRECTED: B1. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORIES FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THESE ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. MEDICAL RECORDS PERTAINING TO THE IMPLANTATION WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL AND IDENTIFIED NO INTRAOPERATIVE COMPLICATIONS. MICROBIOLOGICAL TESTS REVEALED NO GROWTH. MEDICAL RECORDS PERTAINING TO THE REVISION SURGERY WERE PROVIDED AND REVEALED BY A HEALTHCARE PROFESSIONAL, IDENTIFYING THAT EARLY IMAGING SHOWED SLIGHT ACETABULAR CHANGES, WHILE A CONSULTATION REPORTED SEVERE RIGHT HIP AND LEG PAIN BUT NO RADIOGRAPHIC LOOSENING, LIKELY DUE TO A LUMBAR LIGAMENT INJURY. AN UNDATED THERAPY DISCHARGE NOTE INDICATED GOOD RECOVERY AND FULL WEIGHT-BEARING. AFTER THIS, CHROMIUM AND COBALT LEVELS WERE MARKEDLY ELEVATED, WHICH PERSISTED THE NEXT YEAR DESPITE X-RAYS SHOWING NO OSTEOLYSIS OR LOOSENING. SUBSEQUENTLY, REVISION SURGERY WAS PERFORMED FOR HIP PROSTHESIS INSTABILITY, METALLOSIS, AND RIGHT ACETABULAR OSTEOLYSIS, WITH A LOOSE CUP AND EXTENSIVE METAL DEBRIS ADDRESSED DURING THE PROCEDURE. BEHIND THE CUP THERE IS A HUGE DEFECT UP TO THE POSTERIOR LAMELLA WITH PRONOUNCED METALLOSIS. THE STEM IS FIRM, THE STEM CONE IS SCRATCHED AT THE DISTAL END, PROXIMALLY IS THE CONE IS INTACT. PATHOLOGY LATER, CONFIRMED CHRONIC SYNOVITIS WITH SIGNIFICANT METAL ABRASION, WITHOUT INFECTION OR MALIGNANCY. POSTOPERATIVE IMAGING SHOWED STABLE POSITIONING, THOUGH COBALT LEVELS REMAINED HIGHLY ELEVATED (116.3 G/L) IN (B)(6) 2015, WITH CHROMIUM AT 66.2 G/L. FINALLY, FOLLOW-UP TESTING DEMONSTRATED NORMALIZATION OF METAL ION LEVELS. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. HOWEVER, A DEFINITIVE ROOT CAUSE 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 A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, BEGAN TO EXPERIENCE CLICKING, INCREASED PAIN, SUBLUXATION, RADIOGRAPHIC EVIDENCE OF ACETABULAR OSTEOLYSIS, AND LABORATORY EVIDENCE OF ELEVATED METAL IONS AND APPROXIMATELY 13 YEARS POST IMPLANTATION, UNDERWENT A REVISION WHERE THE HIP WAS FOUND DISLOCATED, CUP LOOSE, METALLOSIS, GANGLION, AND NECROTIC BONE. ALL IMPLANTS, EXCEPT FOR THE FIXED STEM, WERE REVISED WITHOUT COMPLICATION. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134177 CLS® SPOTORNO®, STEM, 135°, UNCEMENTED, 9.0, TAPER 12/14 PROSTHESIS, HIP LZO ZIMMER GMBH 2108268

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Hospitalization| R SEE H11 NARRATIVE.