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

Model Number 322.03.636

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) combined report.The appropriate device details were provided, and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.Due to the fact that the fracture occurred following a traumatic episode no further investigation is required 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.

Event Description

A patient who is a parkinson sufferer experienced an episode which led to a fracture of their trochanter and thus a second surgery was performed to repair and re-attach the trochanter.During the procedure the liner and head were removed and replaced with trinity dual mobility devices to minimise the risk of dislocation should the patient suffer another episode.

• Brand Name: TRINITY
• 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
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: sean moule ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 10618496
• MDR Text Key: 209561363
• Report Number: 9614209-2020-00080
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K111481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 322.03.636
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 455172
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/13/2020
• 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
• Treatment: BIOLOX DELTA CERAMIC HEAD - 104.3605, 453782; METAFIX COLLARED STEM - 579.0102, 431376; TRINITY CUP - 321.03.352, 442942
• Patient Outcome(s): Hospitalization; Required Intervention