MAUDE Adverse Event Report: CORIN LTD MOBILIT; ECIMA INSERT FOR 28MM HEAD

Model Number	HDM2848
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per comp (b)(4) - fda initial report.Additional information including x-rays, operative notes, and medical history, 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 will be identified and reviewed.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.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
Mobilit and trinity revision after approximatively 9 months and 2 weeks due to dislocation.
Event or Problem Description
Mobilit and trinity revision after approximatively 9 months and 2 weeks due to dislocation.
Additional Manufacturer Narrative
(b)(4) final report.Additional information requested was provided.The appropriate devices details have been provided and the relevant device manufacturing records have been identified and reviewed.The devices were manufactured according to specifications at the time of manufacture.Based on the provided information, the surgeon confirmed that this dislocation is the consequence of the fall of the patient.The head became misaligned from the insert due to the trauma.Based on the above, the root cause is considered as a patient related issue (trauma / fall).Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contribted to this event.

• Brand Name: MOBILIT
• Common Device Name: ECIMA INSERT FOR 28MM HEAD
• 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: 24425986
• Report Number: 9614209-2026-00027
• Device Sequence Number: 8300458
• Product Code: LZO
• UDI-Device Identifier: 05056139239175
• UDI-Public: 05056139239175
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K191831
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: HDM2848
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 587191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRINITY / COCR HEAD: E321.028 LOT 589742.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 114 LB