MAUDE Adverse Event Report: CORIN LTD MOBILIT CUP; CEMENTLESS CUP TI + HAP

Model Number	HDM654
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4) - initial report.Additional information including, confirmation of the date of revision, confirmation of the devices revised, lot numbers, operative notes, x-rays and medical patient information, 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,oceane+ and metal head revision of the stem, cup, pe insert and head due to infection.Note 1: insert, stem and head are not cleared in the usa.Note 2: this is a regularization within the framework of a clinical study following a change in our event monitoring process of sae from clinical study.
Event or Problem Description
Mobilit / oceane+ / metal head revision of the cup, pe insert, stem and head after approximatively 6 years and 6 months due to infection.Note 1: insert, stem and head are not cleared in the usa.Note 2: this is a regularization within the framework of a clinical study following a change in our event monitoring process of sae from clinical study.
Additional Manufacturer Narrative
Per (b)(4) - 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 CUP
• Common Device Name: CEMENTLESS CUP TI + HAP
• 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: 24493528
• Report Number: 9614209-2026-00033
• Device Sequence Number: 10675882
• 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: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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 Expiration Date: 10/31/2020
• Device Model Number: HDM654
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: NOT APPLICABLE
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2015
• 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: METAL HEAD / HEAD: HZC282 LOT AA1554; METAL HEAD / HEAD: HZC282 LOT TBC; MOBILIT / INSERT: HDM254 LOT AA0705; MOBILIT / INSERT: HDM254 LOT TBC; OCEANE+ / STEM: HCO414 LOT AA0448; OCEANE+ / STEM: HCO414 LOT TBC
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 154 LB