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

Model Number 325.03.040

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2019

Event Type  Injury  

Manufacturer Narrative

Per 2629 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.It was reported that the patient fell 4 weeks post-op, resulting in the peri-prosthetic fracture and subsequent revision.Therefore, this case is now considered closed.Please note: this report is filed with the fda due to an 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 4 weeks due to a peri-prosthetic fracture.

• Brand Name: TRINITY DUAL MOBILITY
• Type of Device: ACETABULAR HIP SYSTEM
• 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: franck didier ; the corinium centre; cirencester; gloucestershire, GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 9494063
• MDR Text Key: 174207273
• Report Number: 9614209-2019-00134
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K107359
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• 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: 431488
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR