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

Model Number 324.03.550

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2019

Event Type  Injury  

Manufacturer Narrative

Per -2547 initial report. Post primary and pre revision x-rays, operative notes, patient medical history, an update on the patient following revision and pre-operative planning documents have been requested in order to progress with the investigation of this event, however, not all could be provided and thus the investigation of this event is limited. It was reported that the explanted devices were not available to return for examination as part of this investigation. The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed. 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 within 1 month due to cup loosening. The exact date of revision is unknown, but was sometime in (b)(6) 2019.

Manufacturer Narrative

Per (b)(4) final report: additional information, including post primary and pre revision x-rays, pre-operative planning documents, operative notes, patient medical history and an update on the patient following the revision, was requested in order to progress with the investigation of this event, however, this information could not be provided and thus the investigation was limited. The explanted devices could not be returned for examination. 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. It was reported to corin that the patient had a significantly deformed acetabulum due to congenital dysplasia and the patient had also pushed too hard too early during the rehabilitation process. Based on this, it has been concluded that this event is a result of patient related conditions and not due to the corin devices and thus this case is now considered closed. 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 cup and ecima liner after 1 month due to cup loosening.

• Brand Name: TRINITY PLUS
• 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: 9382958
• Report Number: 9614209-2019-00119
• 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: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 324.03.550
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 399580
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Age: 36 YR
• Patient Treatment(s): TRINITY ECIMA LINER - 322.03.636, 420436; TRINITY ECIMA LINER - 322.03.636, 420436
• Patient Outcome(s): Hospitalization; Required Intervention