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

Model Number 694.0006

Device Problems Contamination (1120); Device Contaminated During Manufacture or Shipping (2969)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

Per 4253 initial report: investigation of this event is currently in progress.Additional description and photographs of the reported coating on the stem and an update on the patient post-op was requested but could not be provided.The appropriate device details were 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

Prior to implantation of the trifit ts stem, it was observed that there was something like a coating near the top of the stem.

Manufacturer Narrative

Per 4253 - final report.The reported device was not returned to corin for investigation.The appropriate device details were provided.The relevant device manufacturing record was identified and reviewed.It was found that the device was manufactured in nov 2020.A deviation was raised on 06/10/2020 due to white spot on the 10 parts.All the parts have been reworked.The coating supplier was informed of the case.A quality deviation was raised for this issue.Also, they have checked their order documentation and found no anomalies.Unfortunately, the photo is not sufficient for them to make a final assessment of the facts.Also, in case of coating residue, there is no risk to the user or the patient.This coating is biocompatible and is completely absorbed by the organism.Based on the available information, the root cause cannot be determined.No further investigation can be conducted and corin now consider this case closed.Should any additional information be provided, this case may be re-opened.Please note: this report is filled 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 occured outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

Event Description

Prior to implantation of the trifit ts stem, it was observed that there was something like a coating near to the top 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: marie anne euzen ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 12795304
• MDR Text Key: 284987245
• Report Number: 9614209-2021-00136
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 694.0006
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 462253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2020
• 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