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

Model Number 321.04.358

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

Patient Problem Unspecified Infection (1930)

Event Date 12/05/2023

Event Type  Injury  

Event Description

Trinity dual mobility / taperfit revision of the cup, cocr liner, ecima insert, cocr modular head, 2 bone screws, femoral hip stem and cement restrictor after approximately 4 months due to infection.

Manufacturer Narrative

(b)(4).Initial report.Additional information including: "operative notes (primary and revision), x-rays (primary and revision), patient activity level, weight and medical history, did the patient follow correct post-op protocol?, an update on the patient post revision" 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 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 dual mobility / taperfit revision of the cup, cocr liner, ecima insert, cocr modular head, 2 bone screws, femoral hip stem and cement restrictor after approximately 4 months due to infection.

Manufacturer Narrative

(b)(4) final report.Additional information including: "operative notes (primary and revision), x-rays (primary and revision), patient activity level, weight and medical history, did the patient follow correct post-op protocol?, an update on the patient post revision" has been requested, however this information was not provided, and thus the scope of the investigation was limited.The appropriate device details have been provided and the relevant device manufacturing records were identified and reviewed.Review of these records revealed no product nonconformity or deviation from process that would have caused or contributed to the infection.Based on the available information, no further investigation can be conducted, and the root cause of the infection is unknown, however, infection is a known complication of any surgery, and 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.

• Brand Name: TRINITY
• Type of Device: TRINITY ACETABULAR 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: 18311106
• MDR Text Key: 330286057
• Report Number: 9614209-2023-00274
• 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: 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: 321.04.358
• Device Lot Number: 528364
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/08/2023
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 02/12/2024
• 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: TAPERFIT CEMENT RESTRICTOR: 588.0002, 537638; TAPERFIT CEMENT RESTRICTOR: 588.0002, 537638; TAPERFIT HIP STEM: 588.3804, 433395; TAPERFIT HIP STEM: 588.3804, 433395; TRINITY COCR MOD HEAD: E321.128, 465084; TRINITY COCR MOD HEAD: E321.128, 465084; TRINITY DM COCR LINER: 321.04.540, 532701; TRINITY DM COCR LINER: 321.04.540, 532701; TRINITY DM ECIMA INSERT: 325.04.042; TRINITY DM ECIMA INSERT: 325.04.042, 532749; TRINITY SCREW: 321.025, 517203; TRINITY SCREW: 321.025, 517203; TRINITY SCREW: 321.035, 527584; TRINITY SCREW: 321.035, 527584
• Patient Outcome(s): Hospitalization; Required Intervention