MAUDE Adverse Event Report: CORIN LTD TRINITY; ACETABULAR HIP SYSTEM

Model Number 321.04.356

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Joint Laxity (4526)

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

Case-(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes (primary and revision), patient weight, activity level and medical history, how long after primary surgery did the instability start, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary surgery, what was implanted at the revision 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.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 the event.

Event Description

Trinity revision of the cup, ecima liner and biolox delta ceramic head after approximately 1 year and 5 months due to instability.

Manufacturer Narrative

(b)(4) final report.Additional information, including post primary and pre revision x-rays, operative notes (primary and revision), patient weight, activity level and medical history, how long after primary surgery did the instability start, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary surgery, what was implanted at the revision 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 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.It was found that all finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.Post-op documents were identified and reviewed and it was found that the cup and stem had been implanted with 10 degrees higher anteversion that planned pre-op.It has been concluded, based on the available information, that this is the most likely cause of the reported instability 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 the event.

• Brand Name: TRINITY
• Type of Device: ACETABULAR 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: 17875026
• MDR Text Key: 324959649
• Report Number: 9614209-2023-00251
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093472
• 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: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 321.04.356
• Device Lot Number: 484574
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/20/2023
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2021
• 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: TRIFIT TS STEM: 694.0008, 478308; TRINITY BIOLOX DELTA CERAMIC HEAD: 104.3605, 50284; TRINITY ECIMA LINER: 322.04.636, 494111
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 27 YR
• Patient Sex: Male