MAUDE Adverse Event Report: CORIN MEDICAL TRIFIT TS; HIP STEM

Model Number 694.1001

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 02/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) combined report.It was reported that the patient fell post-op, thus resulting in a periprosthetic fracture and the subsequent revision.Operative notes, x-rays, patient medical history and the explants could not be provided.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.As this event was the result of the patient experiencing a periprosthetic fracture following a fall, and not due to the design or performance of the corin devices, 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 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 / trifit ts revision of the ecima liner, ceramic head and stem after 17 days due to periprosthetic fracture following a fall.

• Brand Name: TRIFIT TS
• Type of Device: HIP STEM
• 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: 11436065
• MDR Text Key: 238374414
• Report Number: 9614209-2021-00022
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121563
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2023
• Device Model Number: 694.1001
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 402050
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2018
• 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:104.3210, 385459; TRINITY CUP: 321.02.346, 347004; TRINITY ECIMA LINER: 322.02.632, 445756
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR