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

Model Number 322.03.636

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

Patient Problem Unspecified Infection (1930)

Event Date 09/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) combined report.Additional information, including xrays, operative notes, patient details and an update on the patient following the revision have been requested.It was found that the patient was well following the revision.A xray was provided, post-primary surgery.It was found that the hip implanted with the trinity/metafix system was the right one.It seems that the stem could have been sized up at primary surgery.No further information was available.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 sterilisation method and sterile barrier system used to package trinity and metafix 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 provdied 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/metafix revision due to infection after 1 year and 3 months.

• 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: 10688962
• MDR Text Key: 211654676
• Report Number: 9614209-2020-00088
• 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: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2024
• Device Model Number: 322.03.636
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 419670
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2019
• 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: ACETABULAR SHELL, PART 321.03.350, LOT 422527; BIOLOX MODULAR HEAD, PART 104.3605, LOT 426970; METAFIX FEMORAL STEM, PART 579.0003, LOT 406129
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR