MAUDE Adverse Event Report: CORIN MEDICAL TRINITY DUAL MOBILITY; ACETABULAR HIP SYSTEM WITH ECIMA LINERS

Model Number 325.03.040

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information has been requested in order to aid 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 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.

Event Description

Trinity dual mobility revision after approximately 1 month due to dislocation.

Event Description

Trinity dual mobility revision after approximately 1 month due to dislocation.

Manufacturer Narrative

(b)(4).Final report the patient was reported to have a nuerological disorder and was fitting in bed at the time of dislocation.X-rays, operative notes and the explants could not be provided for the investigation.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.This event was not due to the performance or design of the corin devices but was the result of a patient condition and thus 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: ACETABULAR HIP SYSTEM WITH ECIMA LINERS
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 10725231
• MDR Text Key: 212760134
• Report Number: 9614209-2020-00094
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K170359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 325.03.040
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 452359
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRINITY CUP - 321.03.350, 443057; TRINITY CUP - 321.03.350, 443057; TRINITY DM COCR LINER - 321.03.536, 449740; TRINITY DM COCR LINER - 321.03.536, 449740; TRINITY SCREW - 321.020, 452072; TRINITY SCREW - 321.020, 452072; TRINITY SCREW - 321.025, 450490; TRINITY SCREW - 321.025, 450490; TRINITY SCREW - 321.025, 452252; TRINITY SCREW - 321.025, 452252; TRINITY CUP - 321.03.350, 443057; TRINITY DM COCR LINER - 321.03.536, 449740; TRINITY SCREW - 321.020, 452072; TRINITY SCREW - 321.025, 450490; TRINITY SCREW - 321.025, 452252
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR