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

Model Number 6961009

Device Problems Loose or Intermittent Connection (1371); Migration (4003)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Per -2435 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 shall be identified and reviewed.

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 showed that the stem size was appropriate at implantation and did not show subsidence 4 weeks after surgery.It was also confirmed that no revision occurred and that the patient was not symptomatic.The relevant device manufacturing records were identified and reviewed.All finished parts conformed to dimensional and material specifications at the time of manufacture.The failure mode is not confirmed.Based on this, corin now considers this case closed.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: 9202528
• MDR Text Key: 163117055
• Report Number: 9614209-2019-00105
• 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: 09/25/2020

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 Model Number: 6961009
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 407814
• 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: BIOLOX MODULAR HEAD PART 104.4010, LOT 406921; SCREW PART 321.025, LOT 425320; SHELL PART 321.05.360, LOT 400703; TRINITY LINER PART 322.05.640, LOT 371066
• Patient Outcome(s): Other
• Patient Age: 73 YR