BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLS® SPOTORNO®, STEM, 135°, UNCEMENTED, 7.0, TAPER 12/14

    MDR report key: 21655369 · Received March 20, 2025

    Report

    Report Number
    0009613350-2025-00156
    Event Type
    Injury
    Date Received
    March 20, 2025
    Date of Event
    November 20, 2009
    Report Date
    August 19, 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

    FOLLOW UP REPORT: (B)(4). 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: METASUL® LDH®, HEAD, 42, CODE H, TAPER 18/20, #ITEM: 0100181420, #LOT: 2277583. METASUL® DUROM®, COMPONENT FOR ACETABULUM, #ITEM:0100214048, #LOT: 2232752. METASUL® LDH®, HEAD ADAPTER, M, 0, TAPER 12/14-18/20, #ITEM: 0100185146, #LOT: 2284972. THERAPY DATE: ON (B)(6) 2009. G2: FOREIGN 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 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT, (B)(4). UPDATED: A4, B4, B5, B7, D2, D9, G1, G3, G6, H1, H2, H3, H6. 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 THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND THE PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. INITIAL LEFT TOTAL HIP ARTHROPLASTY PERFORMED. SUBSEQUENTLY, 4 YEARS LATER THE PATIENT UNDERWENT LEFT TOTAL HIP REVISION. DURING THE REVISION, A HUGE TROCHANTERIC BURSA WAS FOUND TO BE SWOLLEN, WITH GREENISH-YELLOW EFFUSION OBSERVED UPON INCISION. THE HEAD WAS REMOVED FROM THE CONE WITHOUT ISSUE, BUT IT APPEARED BLACK WITH SIGNIFICANT WEAR AT THE SHAFT NECK. THE CONE WAS REMOVED, AND A LARGE OSTEOLYSIS WAS NOTED AT THE SHAFT OF THE FEMUR. THE CUP WAS FOUND NOT TO BE OSSEOINTEGRATED. THE WOUND WAS IRRIGATED, AND THE SKIN WAS CLOSED IN LAYERS. BASED ON THE INFORMATION AVAILABLE THE EVENT CAN BE CONFIRMED, BUT A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. 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 FROM LEGAL THAT A PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY PERFORMED. SUBSEQUENTLY, THE PATIENT WAS REVISED 4 YEARS POST-IMPLANTATION. DURING THE REVISION IT WAS NOTED; OSTEOLYSIS OF THE FEMUR, GREENISH-YELLOW EFFUSION, AND BLACK ABUNDANT ABRASION AFTER HEAD REMOVAL. ALL IMPLANTS WERE REVISED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION 4 YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451670 CLS® SPOTORNO®, STEM, 135°, UNCEMENTED, 7.0, TAPER 12/14 HIP PROSTHESIS LZO ZIMMER GMBH 2248983

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R