MAUDE Adverse Event Report: CORIN LTD ICONA; ICONA HIP STEM

Model Number	7260104
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4) initial report.Additional information including post primary and pre revision x-rays, operative notes (primary and revision), patient activity level, weight, bone quality and medical history, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary surgery, what were the factors that led to a size 4 stem being selected and an update on the patient post revision has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
Event or Problem Description
Icona revision of the stem after approximately 6 weeks due to subsidence.
Additional Manufacturer Narrative
(b)(4) final report additional information including post primary and pre revision x-rays, operative notes (primary and revision), patient activity level, weight, bone quality and medical history, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary surgery, what were the factors that led to a size 4 stem being selected and an update on the patient post revision was requested in order to progress with the investigation of this event, however, this information could not be provided and thus the scope of the investigation was limited.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.Review of these records revealed no product non-conformity or deviation from process that would have caused or contributed to the reported event.Based on the above, no further investigation can be conducted and the root cause of the reported subsidence could not fully confirmed, however, icona stems have not been stated as compatible with omni heads and thus it is possible that off-label use caused / contributed to this event.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
Event or Problem Description
Icona revision of the stem after approximately 6 weeks due to subsidence.Please note: an omni head was also revised.

• Brand Name: ICONA
• Common Device Name: ICONA HIP STEM
• Manufacturer (Section D): CORIN LTD; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: franck didier ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 24255604
• Report Number: 9614209-2026-00010
• Device Sequence Number: 12839380
• Product Code: MEH
• UDI-Device Identifier: 05056139247095
• UDI-Public: 05056139247095
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K241472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 7260104
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 592874
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female