MAUDE Adverse Event Report: CORIN LTD TRINITY; COCR MODULAR HEAD

Model Number E321.228

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

Patient Problem Unspecified Infection (1930)

Event Date 02/16/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information including operative notes, patient age and medical history, have already been communicated in order to progress with the investigation of this event.Adverse event documentation 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 and sterilisation 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/ mobilit revision after approximately 1 month due to infection.

Manufacturer Narrative

Per 5293 - final report.The appropriate device details have been provided and the relevant device manufacturing and sterilisation records have been identified and reviewed.These devices were manufactured, packaged and sterilised to the correct specifications at the time of manufacture.The sterilization method and sterile barrier system used to package the corin devices have a long history of safe and effective use at corin for a wide range of orthopaedic devices and has been valided in accordance with the relevant standards.Infection is a known complication with any invasive surgery.The surgeon indicated that the link between the devices and the event is excluded.Based on the above, the root cause of the infection can be considered as external.Therefore, 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.

Event Description

Trinity/ mobilit revision after approximately 1 month due to infection.

• Brand Name: TRINITY
• Type of Device: COCR MODULAR HEAD
• 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: 18756410
• MDR Text Key: 335932952
• Report Number: 9614209-2024-00296
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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 Catalogue Number: NOT APPLICABLE
• Device Lot Number: 543853
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2023
• 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 CUP: HDM654, (B)(6).; MOBILIT CUP: HDM654, (B)(6).; MOBILIT INSERT: HDM2854, (B)(6).; MOBILIT INSERT: HDM2854, (B)(6).
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male