MAUDE Adverse Event Report: CORIN LTD OPS; ORTHOPAEDIC SURGICAL PLANNING AND INSTRUMENT GUIDES

Model Number	1200-0000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We are currently in the process of retrieving further information to perform investigation.We will provide a follow up report upon completion.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
Revision due to ceramic liner fracture.
Event or Problem Description
Revision due to breakage of ceramic liner.
Additional Manufacturer Narrative
(b)(4).Final report.An investigation was launched into this event by the manufacturer.A review of product history records was performed which revealed that no anomalies were observed in the device history records of ops insight which may have caused or contributed to this event.The ops insight plan was made in accordance with specification.There is no indication that ops would have contributed to this event.Based on the available information, the manufacturer has concluded that this event was unrelated to the use of ops technology.There is no evidence to suggest that this issue is systematic.Therefore, no further corrective or preventive action is deemed necessary.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.

• Brand Name: OPS
• Common Device Name: ORTHOPAEDIC SURGICAL PLANNING AND INSTRUMENT GUIDES
• 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: lin htet aung ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 23206709
• Report Number: 9614209-2025-00584
• Device Sequence Number: 13282057
• Product Code: PBF
• UDI-Device Identifier: 09351327000848
• UDI-Public: 09351327000848
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K202805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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 Model Number: 1200-0000
• Device Lot Number: EKW_VY_21128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 12/12/2025
• 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: OPS PATIENT SPECIFIC FEMORAL GUIDE (1250-0100); OPS PATIENT SPECIFIC FEMORAL GUIDE (1250-0100)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male