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

Model Number 6960003

Device Problems Fracture (1260); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Laxity (4526)

Event Date 09/30/2021

Event Type  Injury  

Manufacturer Narrative

Per (b)(4)- initial report.Additional information, including patient age and activity level, patient medical history, date of planification of the revision and to know if the patient experienced any trauma has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details were provided, and the relevant device manufacturing record will be identified and reviewed.

Event Description

Trifit cf pending revision due to fracture and subsidence 10 days post operatively from primary tha.

Manufacturer Narrative

Per 4159 - final report: in order to progress with this investigation, patient age and activity level, patient medical history, date of planification of the revision and to know if the patient experienced any trauma has been requested.Nevertheless, no additional information was communicated by the reporter after 3 reminders.The appropriate device details were provided, and the relevant device manufacturing record will be identified and reviewed.The device reported was manufactured in sept 2020, and the parts conformed to the material and dimensional specifications at the time of manufacture.X-rays were provided which enabled to confirm the fracture and subsidence.It was found that the sizing of the stem was correct at implantation and therefore the subsidence probably occurred due to the bone fracture.Based on this, no further investigation can be conducted, and the root cause of the reported event could not be identified.Therefore, corin now considers this case closed, however, should any additional information be provided, such as the revision, this case may be re-opened for further investigation.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

Trifit cf pending revision due to fracture and subsidence 10 days post operatively from primary tha.

• Brand Name: TRIFIT CF
• Type of Device: HIP STEM
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL71Y J; UK GL71YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: marie anne euzen ; the corinium center; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 12567998
• MDR Text Key: 274468553
• Report Number: 9614209-2021-00116
• 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,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 6960003
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 457911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention