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

Model Number 694.0003

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Per -(b)(4) combined report.Additional information, including post primary and pre revision x-rays, operative notes, patient details and an update on the patient post-op was requested.It was confirmed that the patient was doing well post-op and that the subsidence and subsequent revision was secondary to poor patient bone quality.None of the other information could be provided and the explanted devices could not be returned for examination.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.Based on the available information, no further investigation can be conducted and the root cause of the event could not be determined, however, as stated by the reporter is may be due to the quality of the patient's bone.This case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation.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

Trfit ts / trinity revision of the ceramic head, stem and uhmwpe liner after approximatively 4 years and 3 months due to stem subsidence.

• Brand Name: TRIFIT TS
• Type of Device: 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: 11841283
• MDR Text Key: 251150244
• Report Number: 9614209-2021-00065
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2021
• Device Model Number: 694.0003
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 333529
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2016
• 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
• Treatment: BIOLOX DELTA CERAMIC HEAD:104.3200, 335502; TRINITY CUP: 321.02.348, 332653; TRINITY UHMWPE LINER: 321.02.932, 332388
• Patient Outcome(s): Hospitalization; Required Intervention