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

Model Number 322.04.636

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

Patient Problem Unspecified Infection (1930)

Event Date 11/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) combined report.It was reported that patient is (b)(6), with an unknown level of activity.The primary surgery used ops technology.Additional information, including post primary and pre revision x-rays, operative notes, and an update on the patient following the revision have been requested, but were not provided.The explanted devices were not available to be returned for examination.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records were manufactured, cleaned, packaged and sterilised in accordance with the correct specifications at the time of manufacture.The sterilization method and sterile barrier system used to package trinity devices has a long history of safe and effective use at corin and has been validated in accordance with the relevant standards.Based on the available information no further investigation can be conducted.Infection is a known complication with any invasive surgery and thus this case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.

Event Description

Trinity revision after approximately 2 months due to infection.

• Brand Name: TRINITY
• Type of Device: TRINITY ACETABULAR HIP SYSTEM WITH ECIMA LINERS
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester, gl7 1yj ; UK
• Manufacturer (Section G): CORIN MEDICAL; the corinium center; cirencester, gl7 1yj ; UK
• Manufacturer Contact: sean moule ; the corinium center; cirencester, gl7 1yj ; UK
• MDR Report Key: 10904073
• MDR Text Key: 218243356
• Report Number: 9614209-2020-00111
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 322.04.636
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 456497
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• 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: METAFIX STEM: PART 579.2104, LOT 456171; TRINITY ACETAB. SHELL: PART 321.04.356, LOT 448862; TRINITY BIOLOX HEAD PART: 104.3610, LOT 459308
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR