MAUDE Adverse Event Report: CORIN MEDICAL TRINITY; ACETABULAR HIP SYSTEM WITH ECIMA LINERS

Model Number 322.05.940

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

Per (b)(4)- initial report.Additional information, including post primary and pre revision x-rays, operative notes, patient details, patient medical history, an update on the patient post revision and information regarding stem / femoral head has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details of the ecima liner have been provided and the relevant device manufacturing record will be identified and reviewed.

Event Description

Trinity revision of the ecima liner after approximatively 6 years and 9 months due to a periprosthetic fracture following a fall.

Manufacturer Narrative

Per 4088 - final report additional information, including post primary and pre revision x-rays, operative notes, patient details, patient medical history, an update on the patient post revision and information regarding stem / femoral head was requested in order to progress with the investigation of this event, however, not all information has been received and thus the scope of the investigation was limited.The appropriate device details of the ecima liner were provided and the relevant device manufacturing record has been identified and reviewed.All parts associated with this record conformed to material and dimensional specification at the time of manufacture.There has not been a malfunction or deterioration in the effectiveness of a corin device.The periprosthetic fracture and subsequent revision were due to the patient experiencing a bad fall post primary surgery.Therefore, this case is now considered closed.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 Description

Trinity revision of the ecima liner after approximatively 6 years and 9 months due to a periprosthetic fracture following a fall.

• Brand Name: TRINITY
• Type of Device: ACETABULAR HIP SYSTEM WITH ECIMA LINERS
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: marie-anne euzen ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 12427492
• MDR Text Key: 270044514
• Report Number: 9614209-2021-00107
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 322.05.940
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 425968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2019
• 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
• Treatment: CORIN FEMORAL HEAD: DEVICE DETAILS UNKNOWN; CORIN STEM: DEVICE DETAILS UNKNOWN; FEMORAL HEAD - MODEL UNKNOWN / LOT UNKNOWN; HIP STEM - MODEL UNKNOWN / LOT UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention