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

Model Number 694.1009

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 04/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes, a patient outcome and the explanted device has been requested in order to progress with this investigation, 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

Trifit ts revision after approximately 2 months due to subsidence of the stem.

Manufacturer Narrative

(b)(4) final report.Additional information, including post primary and pre revision x-rays, operative notes, a patient outcome and the explanted device was requested in order to progress with this investigation, however, not all were not provided to corin and thus there was only very limited information available for the investigation.The appropriate device details have been provided and the relevant device manufacturing records have been identified and reviewed.This device conformed to material and dimensional specification.The explanted device was returned to corin for examination.The returned device showed signs of good bone ingrowth and did not show any abnormal characteristics.Based on this, it cannot be determined whether the reported device cause or contributed to the patient's experience and thus corin now consider this case 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

Trifit ts revision after approximately 2 months due to subsidence of the stem.

• Brand Name: TRIFIT TS
• Type of Device: TRIFIT TS 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: franck didier ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ ; 1285659866
• MDR Report Key: 6646045
• MDR Text Key: 77710127
• Report Number: 9614209-2017-00037
• Device Sequence Number: 1
• Product Code: LZO
• 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,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2020
• Device Model Number: 694.1009
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 311125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2015
• 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: 62 YR