MAUDE Adverse Event Report: CORIN MEDICAL 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 Joint Dislocation (2374)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

Per -2499 initial report.X-rays have been provided and will be reviewed at corin along with the relevant device manufacturing records.Details of these reviews will be provided in a supplemental report upon completion of the investigation.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 of the ceramic head and ecima liner after approximately 2 months due to anterior dislocation.

Manufacturer Narrative

Per -2499 final report: the appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.In order to progress with the investigation of this event, post primary and pre revision x-rays, operative notes, patient details and an update on the patient was requested, however, not all was provided and thus the investigation was limited.It was reported to corin that the dislocation was anlteriorly and related to a large posterior pelvic tilt.It has therefore been concluded that the event was a result of patient conditions and not related to the performance of the corin devices 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.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

Event Description

Trinity revision of the ceramic head and ecima liner after approximately 2 months due to anterior dislocation.

• Brand Name: TRINITY
• 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
• MDR Report Key: 9289263
• MDR Text Key: 165563912
• Report Number: 9614209-2019-00113
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K111481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• 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: 429285
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOLOX CERAMIC HEAD - 104.3605, 427615.; BIOLOX CERAMIC HEAD - 104.3605, 427615.; METAFIX STEM - 579.2105, 423639.; METAFIX STEM - 579.2105, 423639.; TRINITY CUP - 321.04.356, 416500.; TRINITY CUP - 321.04.356, 416500.; TRINITY SCREW - 321.040, 396479.; TRINITY SCREW - 321.040, 396479.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR