MAUDE Adverse Event Report: CORIN LTD TRIFIT TS; TRI-FIT HIP SYSTEM

Model Number 694.1003

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

Patient Problem Pain (1994)

Event Date 06/09/2023

Event Type  Injury  

Manufacturer Narrative

Case-(b)(4).Initial report additional information including; operative notes (primary and revision), patient activity level & weight, did the patient follow the correct post-op protocol, did the patient experience any slips/ falls or trauma post primary surgery and an update on the patient post revision has been requested, 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.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

Revision of trifit ts stem, trinity ceramic head and trinity ecima liner after approximately 1 year, 14 weeks due to pain.

Manufacturer Narrative

(b)(4).Final report additional information, including operative notes (primary and revision), whether the patient experienced any slips / falls or other trauma post primary surgery, whether the patient followed correct post-op protocol, patient activity level and an update on the patient post revision was requested in order to progress with the investigation of this event, however, not all this information could not be provided and thus the scope of the investigation was limited.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records conformed to specification at the time of manufacture.Based on the available information, the root cause of the reported pain could not be determined 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.

• Brand Name: TRIFIT TS
• Type of Device: TRI-FIT HIP SYSTEM
• Manufacturer (Section D): CORIN LTD; the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD; the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester; gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 17260543
• MDR Text Key: 318556145
• Report Number: 9614209-2023-00201
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

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 Model Number: 694.1003
• Device Lot Number: 464479
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/09/2023
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 06/09/2023
• Supplement Dates FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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: BIOLOX DELTA CERAMIC HEAD 104.3205, (B)(4).; TRINITY BONE SCREW 321.025, (B)(4).; TRINITY CUP 321.02.348, (B)(4).; TRINITY ECIMA LINER 322.02.632, (B)(4).
• Patient Outcome(s): Hospitalization; Required Intervention