MAUDE Adverse Event Report: CORIN MEDICAL TRINITY ACETABULAR HIP SYSTEM; PE LINER TRIAL NEUTRAL 4 MM EPW SIZE 4/32 MM

Model Number 921.04.932

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 03/14/2022

Event Type  Injury  

Manufacturer Narrative

Per (b)(4) initial report: additional information, including return of the device, if the device broke, if the component of the device fell by accident due to incorrect handling, if the surgeon did anything unusual during the procedure and the location of the ring part inside the patient has been requested in order to progress with the investigation of this event; 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 record 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.

Event Description

The ring part of the trinity pe liner trial fell off and remained in the patient's body.

Manufacturer Narrative

It was reported that the metal circlip of a trinity liner trial came off and remained in the patient.There has not been any adverse health impact reported as a result of this event.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.It was found that all parts associated with these records conformed to material and dimensional specification at the time of manufacture.Corin has not received any other reports relating to parts from this batch and this is the 1st report whereby this part of the instrument has come off and been left in the patient.The reported device was returned and the failure mode was confirmed.X-rays provided show that the circlip was located in the surrounding tissue away from the joint space.The root cause of this event cannot be determined, however, based on the size of the circlip and it subsequently being missing from the liner trial, this failure should have been detected during surgery, prior to closing up the patient.There is no indication at this time that the failure could be related to the batch or to the device design 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.

Event Description

It was confirmed that the ring part of the liner trial remained in the body by the x-ray photograph after the wound was closed.

• Brand Name: TRINITY ACETABULAR HIP SYSTEM
• Type of Device: PE LINER TRIAL NEUTRAL 4 MM EPW SIZE 4/32 MM
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester, GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium center; cirencester
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 13899755
• MDR Text Key: 287888728
• Report Number: 9614209-2022-00018
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 07/28/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 921.04.932
• Device Catalogue Number: N/A
• Device Lot Number: 328590-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 03/25/2022
• Supplement Dates Manufacturer Received: 03/17/2022
• Supplement Dates FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2016
• 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
• Patient Outcome(s): Other