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

Model Number 325.03.040

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

Patient Problem Bone Fracture(s) (1870)

Event Date 03/27/2022

Event Type  Injury  

Manufacturer Narrative

Per (b)(4) combined report. The reporter stated that the patient fell post primary and fractured their femur so the stem (non-corin device) had to be revised. As part of this revision a non-corin head and the corin trinity dual mobility ecima insert were also revised. There has been no reported fault with the corin device. The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed. It was found that all finished parts associated with this record conformed to material and dimensional specification at the time of manufacture. 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 after 10 days due to a femoral fracture from a fall. A non-corin head and stem were also revised.

• Brand Name: TRINITY DUAL MOBILITY
• 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: 14052129
• MDR Text Key: 288860664
• Report Number: 9614209-2022-00023
• 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

• Type of Report: Initial
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 325.03.040
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 476363
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/08/2022 Patient Sequence Number: 1