MAUDE Adverse Event Report: CORIN MEDICAL TRINITY DUAL MOBILITY; ACETABULAR HIP SYSTEM

Model Number 325.05.045

Device Problem No Apparent Adverse Event (3189)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/25/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) combined report.The reporter has confirmed that there was no issue with the trinity dual mobility ecima insert and that it was removed as a necessity, along with a non-corin head and stem.The patient fell post primary surgery, resulting in a femoral perirosthetic fracture and the subsequent revision.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufature.As the revision was caused by the patient experiencing a fall post primary and fracturing their femur, no further investigation is required and thus this case is now considered closed.

Event Description

Revision of a trinity dual mobility ecima insert due to the patient experiencing a fall and subsequent periprosthetic femoral fracture post primary surgery.A non-corin stem and head were revised.The reporter has stated that there was no issue with the corin device and that it was only removed as a necessity.

• Brand Name: TRINITY DUAL MOBILITY
• Type of Device: ACETABULAR HIP SYSTEM
• 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: 12588500
• MDR Text Key: 275144469
• Report Number: 9614209-2021-00117
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 325.05.045
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 445769
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention