MAUDE Adverse Event Report: CORIN LTD CORMET; HIP RESURFACING SYSTEM

Model Number NOT PROVIDED

Device Problem Insufficient Information (3190)

Patient Problem Metal Related Pathology (4530)

Event Date 10/17/2023

Event Type  Injury  

Event Description

Potential cormet revision due to elevated metal ions.Please note: the device part nos.And lot codes have not been provided at this stage, it has just been stated that they were cormet devices.

Manufacturer Narrative

(b)(4) initial report.The device part nos.And lot codes have been requested, and if received, an investigation into this event will be conducted.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.

Manufacturer Narrative

Case (b)(4).Final report.The device part nos.And lot codes were requested, but could not be provided.The reporter has confirmed that no further information is available at this time.Based on this, corin are unable to confirm that the event involves any corin devices and no investigation can be conducted.Therefore, this case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation.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: CORMET
• Type of Device: HIP RESURFACING SYSTEM
• 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: dardan uka ; the corinium centre; cirencester; gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 18029077
• MDR Text Key: 326845638
• Report Number: 9614209-2023-00261
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NOT PROVIDED
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/17/2023
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male