MAUDE Adverse Event Report: CORIN LTD TRINITY DUAL MOBILITY; TRINITY DUAL MOBILITY HEAD INSERT PRESS

Model Number 9210305013

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 06/04/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial report.The affected device will be returned to corin and examined.The appropriate device details have been provided and the relevant device manufacturing record will be identified and reviewed.Investigation detail will be provided in a supplemental report.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 head insert press: the black trunnion part of the compression jig bent when pressing the two heads together.This led to a surgical delay of over 30 minutes.

Manufacturer Narrative

(b)(4) final report.The appropriate device details were provided and the relevant device manufacturing record has been identified and reviewed.All parts associated with this record conformed to material and dimensional specification at the time of manufacture.The device was not returned to corin for examination, however, photographs were provided by the reporter which confirm the failure mode.Corin has initiated a project to investigate this failure and research a new design to improve the durability of this instrument 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 DUAL MOBILITY
• Type of Device: TRINITY DUAL MOBILITY HEAD INSERT PRESS
• 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: 17151071
• MDR Text Key: 317471420
• Report Number: 9614209-2023-00196
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170359
• 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: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9210305013
• Device Lot Number: 093209-08
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/04/2023
• Date Manufacturer Received: 06/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization