MAUDE Adverse Event Report: CORIN LTD MOBILIT; CUP CEMENTED

Model Number	HDM560
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4)- initial report.Additional information, including confirmation of the lot code of the cup, date of implantation, operative notes, x-rays and medical history of the patient, 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.
Event or Problem Description
Mobilit revision of the cup and pe insert due to infection.Note: the insert hdm260 is not cleared in the usa.
Event or Problem Description
Mobilit revision of the cup and pe insert due to infection.Note: the insert hdm260 is not cleared in the usa.
Additional Manufacturer Narrative
Per (b)(4) - final report.Additional information, including confirmation of the lot code of the cup, date of implantation, operative notes, x-rays and medical history of the patient, has been requested in order to progress with the investigation of this event.However, this information was not available at the time of closure.The appropriate devices details of the insert have been provided and the relevant device manufacturing and sterilisation record have been identified and reviewed.The device was 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.Note: the appropriate device details of the cup were not communicated, thus the device manufacturing record, and sterilisation record were not identified and reviewed.Based on the above, no further investigation can be conducted.The root cause is considered as not determined, however has not been directly linked to the device.Corin now consider 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: CUP CEMENTED
• 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: 24266879
• Report Number: 9614209-2026-00016
• Device Sequence Number: 10723430
• Product Code: LZO
• UDI-Device Identifier: 05056139200830
• UDI-Public: 05056139200830
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K191831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/29/2026

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: HDM560
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: UNKNOWN
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: MOBILIT / INSERT: HDM260 LOT 467627; MOBILIT / INSERT: HDM260 LOT 467627
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown