BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLS SPOTORNO, EXPANSION SHELL, UNCEMENTED, ø 58

    MDR report key: 21315366 · Received February 5, 2025

    Report

    Report Number
    0009613350-2025-00048
    Event Type
    Injury
    Date Received
    February 5, 2025
    Date of Event
    December 19, 2024
    Report Date
    July 28, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 1. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10. BIOLOX® FORTE, HEAD, S, ø 28/-3.5, TAPER 12/14 ITEM# 122805 LOT# 2200733. 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, D9, D10, G3, G6, H2, H3, H6, H11. D10. BIOLOX® FORTE, HEAD, S, ø 28/-3.5, TAPER 12/14 ITEM# 122805 LOT# 2200733. CLS CUP INSERT 28/58 ITEM# 68.13.28-58 LOT# 2162506. CLS STEM 135DEG 10.0 12/14 ITEM# 290039100 LOT# 2188863. THE REPORTED PRODUCTS WERE RETURNED TO THE PRODUCT SURVEILLANCE TEAM FOR EXAMINATION. A PORTION OF THE CLS SPOTORNO EXPANSION CUP HAS FRACTURED OFF, WITH THE FRAGMENT BEING RETURNED. THE CUP SHOWS SIGNS OF REVISION IN THE FORM OF A DEFORMED SHELL AS WELL AS SUPERFICIAL AND DEEPER SCRATCHES. NO BONE ATTACHMENTS COULD BE OBSERVED ON THE ANCHORING SIDE OF THE CLS SHELL. INSTEAD, THE SEATING SURFACE OF THE CUP SHOWS SIGNS OF LOOSENING IN THE FORM OF POLISHED SURFACES. NOTABLY, THERE ARE POLISHED SPOTS TO BE SEEN WITHIN THE ARTICULATING SURFACE OF THE CUP, LIKELY DUE TO MICROMOTION FROM THE INSERT. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. THE RETRIEVALS AT HAND WERE REVISED AFTER APPROXIMATELY 20 YEARS AND 9 MONTHS IN-VIVO. BASED ON THE RETURNED COMPONENTS AND VISUAL INSPECTION, THE DAMAGE PATTERN OBSERVED SUGGESTS THAT IMPINGEMENT AND RIM-LOADING POTENTIALLY CONTRIBUTED TO BOTH THE FRACTURE OF THE CUP AND LOOSENING OF THE COMPONENTS AT BOTH THE INLAY-TO-CUP AND CUP-TO-ACETABULUM INTERFACES. IT REMAINS UNCLEAR WHETHER FRACTURE OR LOOSENING OCCURRED FIRST, AS NO IMAGING (E.G., X-RAYS) OR MEDICAL RECORDS WERE PROVIDED TO CONFIRM COMPONENT POSITIONING OR CLINICAL PROGRESSION. AS FURTHER CLINICAL INFORMATION IS NOT AVAILABLE (SURGICAL REPORTS OF REVISION, PATIENT¿S MEDICAL HISTORY ETC.) ANY INFLUENCING FACTORS THAT MAY RESULT FROM IT REMAIN UNKNOWN. BASED ON THE GIVEN INFORMATION AND RESULTS OF THE INVESTIGATION, 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 THAT THE PATIENT HAD A HIP REPLACEMENT. SUBSEQUENTLY, APPROXIMATELY 21 YEARS POST IMPLANTATION UNDERWENT A REVISION SURGERY DUE TO DESTROYED ACETABULUM, POSSIBLE PREMATURE LOOSENING AND POSSIBLE RISK OF FOREIGN BODIES. DUE DILIGENCE IS IN PROCESS AND TO DATE NO ADDITIONAL INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A HIP REPLACEMENT ON AN UNKNOWN DATE. SUBSEQUENTLY, APPROXIMATELY 21 YEARS POST IMPLANTATION UNDERWENT A REVISION SURGERY DUE TO DESTROYED ACETABULUM, POSSIBLE PREMATURE LOOSENING AND POSSIBLE RISK OF FOREIGN BODIES. DUE DILIGENCE IS IN PROCESS AND TO DATE NO ADDITIONAL 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
    60481 CLS SPOTORNO, EXPANSION SHELL, UNCEMENTED, ø 58 PROSTHESIS, HIP LZO ZIMMER GMBH 2169190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11 NARRATIVE.| SEE H11 NARRATIVE.