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

Model Number E321.128

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

Patient Problem Unspecified Infection (1930)

Event Date 09/28/2023

Event Type  Injury  

Manufacturer Narrative

Case (b)(4).Initial report additional information, including part number and lot code of the insert, operative notes, medical history of the patient, have been requested to the reporter.Available information will be detailed in a supplemental report.The relevant device manufacturing records will be identified and reviewed.Conclusions will be provided in a supplemental report.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 occured 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 / mobilit revision after approximatively 2 weeks due to infection.

• Brand Name: TRINITY
• 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 centre; cirencester GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 18700018
• MDR Text Key: 335292797
• Report Number: 9614209-2024-00294
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2024

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: E321.128
• Device Catalogue Number: N/A
• Device Lot Number: 536967
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/06/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Date Device Manufactured: 07/02/2023
• 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: MOBILIT / INSERT: PART AND LOT CODE TO BE CONFIRME
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male