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

Model Number 6960006

Device Problems Malposition of Device (2616); Migration (4003)

Patient Problems Discomfort (2330); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report: additional information 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.Upon receipt of the appropriate device details, the relevant device manufacturing records will be identified and reviewed.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 stem subsidence - patient may require a revision.

Manufacturer Narrative

Per -(b)(4) final report in order to progress with the investigation of this event, corin requested the device details, operative notes, patient age and activity level, and patient medical history, but they were not provided.Examination of the post-surgery x-rays did not enable to confirm the subsidence, as no xray performed immediately post-surgery was provided.An xray performed 12 weeks post-surgery showed that the size of the implanted stem was appropriate.It was also confirmed that no revision occurred and that the patient reported to feel a little short when she was barefoot.The devices details were provided and thus the relevant device manufacturing records were identified and reviewed.All finished parts conformed to dimensional and material specifications at the time of manufacture, except for the femoral head material.However, the femoral head material has no impact on the stem stability and therefore the rootcause of the subsidence is unknown.Based on this, corin now considers this case closed.Should additional information be provided, the case will be reopened.Please note: the date of the event is unknown as the date on which the subsidence was observed was not provided.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 stem subsidence - patient may require a revision.

• 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: 9202530
• MDR Text Key: 163120875
• Report Number: 9614209-2019-00106
• 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
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2024
• Device Model Number: 6960006
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 407615
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUAL MOBILITY LINER PART 321.03.536, LOT 419624; ECIMA INSERT : PART 325.03.040, LOT 411044; ECIMA LINER: PART 322.03.636, LOT 408000; MODULAR HEAD PART 104.2805, LOT 420958; SCREW: PART 321.025, LOT 409867; SHELL PART 321.03.350, LOT 409868
• Patient Outcome(s): Other
• Patient Age: 65 YR