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

Model Number 6961008

Device Problem Fracture (1260)

Patient Problem Fall (1848)

Event Date 11/01/2020

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 parts associated with these records conformed to material and dimensional specification at the time of manufacture.As the peri-prosthetic fracture and subsequent revision were the result of the patient experiencing a fall, no further investigation is required and thus this case is now considered closed.

Event Description

Trift cf / trinity revision of the femoral stem and ceramic head after approximately 1 month due to the patient sustaining a peri-prosthetic femur fracture following a fall.

• Brand Name: TRIFIT CF
• 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: 10861354
• MDR Text Key: 216885151
• Report Number: 9614209-2020-00108
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173880
• 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: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2024
• Device Model Number: 6961008
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 382035
• Date Manufacturer Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2019
• 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
• Treatment: BIOLOX DELTA CERAMIC HEAD - 104.3610, 459303
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR