MAUDE Adverse Event Report: CORIN LTD TRINITY; TRINITY-I ACETABULAR SHELL

Model Number 321.03.350

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

Patient Problem Pain (1994)

Event Date 10/16/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information, including operative notes (primary and revision).What was implanted at the revision, how long after primary surgery did the pain and tightness start 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 this event.

Event Description

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

Manufacturer Narrative

(b)(4).Final report.Additional information, including operative notes (primary and revision).What was implanted at the revision, how long after primary surgery did the pain and tightness start and an update on the patient post revision, was requested in order to progress with the investigation of this event, however, this information was not 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.Review of these records revealed no product non-conformity or deviation from process that would have caused or contributed to this event.It was identified that the limb length was 5mm more than planned and the cup offset was 10mm more than planned.Based on the available information, it has been concluded that the increased cup offset was the most likely cause of the reported pain 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: TRINITY
• Type of Device: TRINITY-I ACETABULAR SHELL
• Manufacturer (Section D): CORIN LTD; the corinium centre; cirencester; gloucestershire GL7 1 ZG; UK GL7 1ZG
• 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: 18029037
• MDR Text Key: 326844877
• Report Number: 9614209-2023-00260
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122305
• 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: 01/10/2024

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: 321.03.350
• Device Lot Number: 523757
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/16/2023
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 10/16/2023
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2023
• 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: 104.3600, 528741; METAFIX COLLARED STEM: 579.0103, 508621; TRINITY ECIMA LINER: 322.03.636, 521597
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female