MAUDE Adverse Event Report: CORIN LTD (UK & FR) TRINITY ACETABULAR HIP SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number E321.228

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

Patient Problem Bacterial Infection (1735)

Event Date 09/14/2023

Event Type  Injury  

Event Description

Trinity insert and head revision due to infection after 1 month.The is the patient second revision for infection ( refer to report 9614209-2023-00240).

Manufacturer Narrative

(b)(4), initial report.Additional information including post primary and pre revision x-rays, operative notes (primary and revision), patient activity level and medical history and an update on the patient post revision has been requested in order to progress with the investigation of this event.The appropriate device details have been provided.The relevant device manufacturing records will be identified and reviewed.Conclusion of the investigation will be provided in a supplemental report.Please note: 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.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.

Manufacturer Narrative

(b)(4) final report.Additional information including post primary and pre revision x-rays, operative notes (primary and revision), patient activity level and medical history and an update on the patient post revision has been requested in order to progress with the investigation of this event.However, this information was not provided, therefore the scope of the event was limited.The appropriate device details have been provided and the relevant device manufacturing and sterilization records were identified and reviewed.Review of these records revealed no deviation from process or product non-conformity that would have caused the reported event.Infection is a known complication with any invasive surgery.Based on the available information, the root cause of the reported infection could not be determined 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.

• Brand Name: TRINITY ACETABULAR HIP SYSTEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): CORIN LTD (UK & FR); the corinium centre; cirencester GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD (UK & FR); the corinium center; love ln, love lane industrial; cirencester GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium center; love ln, love lane industrial; cirencester GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 17851240
• MDR Text Key: 324684184
• Report Number: 9614209-2023-00246
• Device Sequence Number: 1
• Product Code: LWJ
• 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: 02/12/2024

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: E321.228
• Device Lot Number: 482578
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/14/2023
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 02/12/2024
• Date Device Manufactured: 07/29/2021
• 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: TRINITY INSERT 325.04.042 LOT 536684
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male