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

Model Number	HDM2850
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per comp (b)(4) - initial report.Additional information including operative notes, x-rays and update of 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 requested and the relevant device manufacturing records 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 occured 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, trinity and meije duo revision of the cup, ecima insert, modular head and stem due to infection.Note 1: this is the 2nd revision for this patient (1st revision managed under file 9614209-2026-00017).Note 2: the part hlp413 is not cleared in the usa.
Event or Problem Description
Mobilit, trinity and meije duo revision of the cup, ecima insert, modular head and stem after approximatively 5 months and 1 week due to infection.Note 1: this is the 2nd revision for this patient (1st revision managed under file 9614209-2026-00017).Note 2: the part hlp413 is not cleared in the usa.
Additional Manufacturer Narrative
Per comp 2172 - final report.Additional information requested was provided.The appropriate devices details have been provided and the relevant device manufacturing and sterilisation records have been identified and reviewed.The devices were manufactured, packaged and sterilised according to specifications at the time of manufacture.The cleaning method, the sterilisation method and sterile barrier system used to package our devices have a long history of safe and effective use at corin for a wide range of orthopedic devices and has been validated in accordance with the relevant standards.Infection is a known complication with any invasive surgery.Based on the above, no further investigation can be conducted.As the surgeon confirmed that the link between the devices and the event is excluded, the root cause is considered as external.Corin consider now this case closed.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 occured 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.

• 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: 24398999
• Report Number: 9614209-2026-00025
• Device Sequence Number: 8223592
• Product Code: LZO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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: HDM2850
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 595661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MEIJE DUO / STEM: HLP413 LOT 573755; MEIJE DUO / STEM: HLP413, LOT 573755; MOBILIT / CUP: HDM650 LOT 591854; MOBILIT / CUP: HDM650, LOT 591854; TRINITY / COCR HEAD: E321.428 LOT 587037; TRINITY / COCR HEAD: E321.428, LOT 587037
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 226 LB