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

Model Number 322.04.636

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 08/04/2021

Event Type  Injury  

Manufacturer Narrative

Per -(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes, primary usage information of all components, patient details and an update on the patient post revision has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.

Event Description

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

Manufacturer Narrative

Per -4023 final report.Additional information, including post primary and pre revision x-rays, operative notes, primary usage information of all components, patient details and an update on the patient post revision was requested in order to progress with the investigation of this event, however, not all information could be provided.The appropriate device details were provided and the relevant device manufacturing and sterilisation records have identified and reviewed.Review of these records revealed no deviation from process or non-conformity of product that would have caused or contributed to the adverse event.Infection is a known complication with any invasive surgery and thus this case is now considered closed.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 ecima liner and ceramic head after approximately 2 months due to infection.

• 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: 12311866
• MDR Text Key: 266153767
• Report Number: 9614209-2021-00096
• 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: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• 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: 469956
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOLOX DELTA CERAMIC HEAD: 104.3615, 468750; BIOLOX DELTA CERAMIC HEAD: 104.3615, 468750; TRIFIT CF STEM: 6961010, 407816; TRINITY CUP: 321.04.358, 461039; BIOLOX DELTA CERAMIC HEAD: 104.3615, 468750
• Patient Outcome(s): Hospitalization; Required Intervention