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

Model Number 6961009

Device Problems Fracture (1260); Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 01/13/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report additional information, including post primary and pre revision x-rays, operative notes, patient details, patient medical history and an update on the patient following the revision 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.It has been stated that the explanted device cannot be returned for examination.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.

Event Description

Trifit cf revision after 25 days due to stem fracture and subsidence, it has been reported that the patient has parkinsons and declining comprehension so they are unsure if they fell or not.

Manufacturer Narrative

Per (b)(4) final report additional information, including post primary and pre revision x-rays, operative notes, patient details, patient medical history and an update on the patient following the revision was requested in order to progress with the investigation of this event, however, none of this information has been provided and thus the scope of the investigation was limited.It was reported that the explanted device could not be returned for examination.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.It was reported that the patient suffers from parkinson's and declining comprehension and thus was unsure if they had fallen.This cannot be confirmed wth the available information and no further investigation can be conducted.Therefore, this case is now considered closed.However, should any additional information be provided then 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 revision after approximately 1 month due to reported stem fracture and subsidence.It has been reported that the patient has parkinsons and declining comprehension so they are unsure if they fell or not.

Event Description

Trifit cf revision after approximately 1 month due to reported stem fracture and subsidence.It has been reported that the patient has parkinsons and declining comprehension so they are unsure if they fell or not.Since submission of the final report for this event, corin has receieved information that the fracture was not of the stem but was actually a periprosthetic bone fracture.X-rays were provided which confirm this.

Manufacturer Narrative

Per -3491 final report following submission of the final report for this event, two x-rays were provided and it has been confirmed that the fracture was actually a bone fracture not a stem fracture.Additional information, including post primary and pre revision x-rays, operative notes, patient details, patient medical history and an update on the patient following the revision was requested in order to progress with the investigation of this event, however, not all of this information has been provided and thus the scope of the investigation was limited.It was reported that the explanted device could not be returned for examination.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.It was reported that the patient suffers from parkinson's and declining comprehension and thus was unsure if they had fallen.There is a potential that the patient did fall, resulting in the bone fracture, however, this cannot be confirmed wth the available information and no further investigation can be conducted.Therefore, this case is now considered closed.However, should any additional information be provided then 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.

• 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
• MDR Report Key: 11206527
• MDR Text Key: 227924335
• Report Number: 9614209-2021-00016
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K173880
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6961009
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 439193
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention