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

Model Number 694.1006

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information, including post primary and pre revision x-rays, the explanted devices, operative notes and patient medical history has been requested in order to progress with this investigation, and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.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

Trifit ts revision after approximately 1 year and 7 months.

Manufacturer Narrative

(b)(4) final report.Additional information, including post primary and pre revision x-rays, operative notes, patient age and activity level, patient medical history and the return of the explanted devices was requested in order to progress with this investigation, however, not all were provided and thus there was only very limited information available for the investigation.It was confirmed that the explanted devices were discarded by the hospital following the revision and therefore, could not be examined.The appropriate device details were provided and the relevant device manufacturing records were identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.Based on the information available for this event, no further investigation can be conducted and thus corin now consider this case closed.However, if additional information becomes available 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

Trifit ts revision after approximately 1 year and 7 months.It was reported that the revision was required due to aseptic loosening.

• Brand Name: TRIFIT TS
• Type of Device: TRIFIT TS 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: franck didier ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ ; 1285659866
• MDR Report Key: 6810126
• MDR Text Key: 83228299
• Report Number: 9614209-2017-00055
• Device Sequence Number: 1
• Product Code: LZO
• 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,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2019
• Device Model Number: 694.1006
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 296319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2014
• 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 104.3610, 313704
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR