MAUDE Adverse Event Report: CORIN LTD TRINITY; BIOLOX DELTA CERAMIC HEAD

Model Number 104.3600

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4) summary report: additional information including: date of primary surgery, what are the associated devices, were they revised, how was it identified that the incorrect sized head was implanted were requested.The reporter responded, providing the date of the primary surgery, and details for the associated devices (none were revised).The reporter stated: "it was very noticeable from the x-ray that the head wasn't seated correctly in the liner and then they were able to see from the implant book that they'd used the wrong size.It was user error, the boxes were labelled correctly, there was a mishap with staff checking." the device details were provided and the manufacture records reviewed.The device label was found to show the correct details.The root cause of this event is determined to be user error.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 ceramic head revision after 1 week due to incorrect sized head being implanted into the patient: a 36mm head was used with a 32mm liner.

• Brand Name: TRINITY
• Type of Device: BIOLOX DELTA CERAMIC 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: 18748044
• MDR Text Key: 335878457
• Report Number: 9614209-2024-00295
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110087
• 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
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 104.3600
• Device Lot Number: 548544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Distributor Facility Aware Date: 02/05/2024
• Date Manufacturer Received: 02/05/2024
• Date Device Manufactured: 11/24/2023
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female