MAUDE Adverse Event Report: CORIN LTD MODULAR HEAD TRIAL

Model Number E922.128

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial report.The reporter has responded to say that all the fragments of the trial were removed, and it is believed that the surgeon attached the head trial by hand.Upon receipt of the device lot code, the manufacturing records will be identified and reviewed.Please note: this event involves a device that is similar to those placed on the market in the usa, however, this event occurred outside 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

28 medium head seemed to chip during the trial reduction, small bits of blue plastic left on the top of the stem.It was reported that the blue plastic pieces were retrieved and none were left in the joint.

Manufacturer Narrative

(b)(4) final report.Additional information requested including: were all fragments of the head trial removed?, was the correct surgical technique used? was the head trial fitted by hand or impacted? the reporter has responded to say that all the fragments of the trial were removed, and it is believed that the surgeon attached the head trial by hand.The device lot code is not legible, and therefore no further investigation can be conducted at this time, and the root cause is not determined.This case is now considered closed.Please note: this event involves a device that is similar to those placed on the market in the usa, however, this event occurred outside 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: MODULAR HEAD TRIAL
• Type of Device: MODULAR HEAD TRIAL
• Manufacturer (Section D): CORIN LTD; the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD; corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; corinium centre; cirencester; gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 18176419
• MDR Text Key: 328636346
• Report Number: 9614209-2023-00268
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142761
• 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: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E922.128
• Device Lot Number: NOT VISIBLE
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/07/2023
• Date Manufacturer Received: 11/07/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TRINITY MODULAR HEAD TRIAL: E922.128, UNKNOWN.