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

Model Number	HDM652
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Mobility & metal head revision after approximatively 8 years and 6 months due to loosening of the cup.Note: the mobility insert (hdm252) and the metal head (hzc282) are not cleared in the usa.
Additional Manufacturer Narrative
Per comp (b)(4) initial report.Additional information, including operative notes, x-rays, serious adverse event document (sae), medical history of the patient and if the patient experienced any trauma, has been requested in order to progress with the investigation of this event.Available information will be detailed in a supplemental report.The appropriate device details have been requested.The relevant device manufacturing records will be identified and reviewed.Conclusions will be provided in a supplemental report.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.
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 records have been identified and reviewed.The devices were manufactured according to specifications at the time of manufacture.The surgeon did a comparison between the 2017 images with the current ones.He confirmed in the operative notes that there is a tilt with verticalization of the cup and asymmetry suggesting wear of the pe in the cup or an intraprosthetic dislocation.Based on the above, and due to the fact that the devices were not returned and the x-rays not communicated, no further investigation can be conducted.It is not possible to determine if the event is due to a wear of the pe or an intraprosthetic loosening.The root cause cannot be determined.Corin now considers this case closed.Nb/ the lot code of the metal head hzc282 was updated following error of the reporter.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 & metal head revision after approximatively 8 years and 6 months due to loosening of the cup.Note: the mobilit insert (hdm252) and the metal head (hzc282) are not cleared in the usa.

• Brand Name: MOBILIT
• Common Device Name: MOBILIT CUP 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: 23756108
• Report Number: 9614209-2025-00627
• Device Sequence Number: 13141835
• Product Code: LZO
• UDI-Device Identifier: 05056139200892
• UDI-Public: 05056139200892
• 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: 2017
• Device Explanted Year: 2025
• 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): 03/03/2025

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: 03/16/2022
• Device Model Number: HDM652
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: AA9606014
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2017
• 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 AA1661005.; METAL HEAD / HEAD: HZC282 LOT AB0474011.; MOBILIT / INSERT: HDM252 LOT AA8663001.; MOBILIT / INSERT: HDM252 LOT AA8663001.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 60 KG