MAUDE Adverse Event Report: CORIN MEDICAL UNKNOWN

Model Number NOT PROVIDED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Insufficient Information (4580)

Event Date 10/18/2020

Event Type  Death  

Manufacturer Narrative

Per (b)(4) initial report: it has been reported to corin that a patient has died post-op following a corin total hip replacement.It has been reported that the corin devices are not thought to have contributed to the death of the patient, however, corin has requested the device details, patient medical history, cause of death and whether the patient had any pre-existing medical conditions which could have contributed to this event.If this information is received it will be provided in a supplemental report upon completion of the investigation.Upon receipt of the appropriate device details the relevant device manufacturing records will be identified and reviewed.

Event Description

It has been reported that a patient was having a corin total hip replacement and then coded on the table.The procedure was finished but the patient is reported to have died.Please note: the corin device details are currently unknown, however, it has been reported that the devices are not thought to have contributed to the events.

Event Description

It has been reported that a patient was having a corin total hip replacement and then coded on the table.The procedure was finished but the patient is reported to have died.Please note: the corin devices are currently unknown, however, it has been reported that the devices are not thought to have contributed to the event.

Manufacturer Narrative

(b)(4) - final report.It has been reported to corin that a patient has died post-op following a corin total hip replacement.It has been reported that the corin devices are not thought to have contributed to the death of the patient.The appropriate device details were not provided, consequently the relevant device manufacturing records have not been identified and reviewed.As we don't have more information on the cause of the death, nor on the pre-existing medical conditions, no further investigation can be conducted.Based on this, corin now considers this case closed.Should any additional information be provided, this case may be re-opened.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: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 10726755
• MDR Text Key: 212733886
• Report Number: 9614209-2020-00096
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

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
• Device Operator: Health Professional
• Device Model Number: NOT PROVIDED
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 10/19/2020
• Supplement Dates FDA Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 82 YR