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

Model Number 325.05.045

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report. There has been no reported malfunction of the corin devices associated with this report. A trinity dual mobility ecima insert was revised along with a non-corin stem and head due to subsidence of the stem. The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed. Details of this review will be provided in a supplemental report upon completion of the investigation.

Event Description

Revision of a trinity dual mobility ecima insert after 2 weeks due to subsidence of a non-corin stem. A non-corin stem and head were also revised. There has been no fault with the corin device.

• 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: 13937828
• MDR Text Key: 288099793
• Report Number: 9614209-2022-00020
• 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,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 325.05.045
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 473175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• 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: 03/29/2022 Patient Sequence Number: 1

Treatment

TRINITY CUP: 321.05.360, 483670; TRINITY DM COCR LINER: 321.05.540, 473911; TRINITY SCREW: 321.025, 485323; TRINITY SCREW: 321.025, 486405