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

Model Number 694.0003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes, patient age, patient activity level, patient medical history, an update on the patient following the revision and whether they had experienced any trauma prior to the pain, 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.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 / trinity revision of the stem, ecima liner and ceramic head after approximately 2 years and 11 months due to the patient experiencing thigh pain.

Event Description

Trifit ts / trinity revision of the stem, ecima liner and ceramic head after approximately 2 years and 11 months due to the patient experiencing thigh pain.

Manufacturer Narrative

Per -3575 final report.Additional information, including post primary and pre revision x-rays, operative notes, patient age, patient activity level, patient medical history, an update on the patient following the revision and whether they had experienced any trauma prior to the pain, was requested in order to progress with the investigation of this event, however, this information could not be provided and thus the scope of the investigation was limited.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, the root cause of the reported pain could not be determined 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.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.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 TS
• Type of Device: HIP STEM
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 11365368
• MDR Text Key: 233081277
• Report Number: 9614209-2021-00021
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K121563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2021
• Device Model Number: 694.0003
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 339387
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOLOX DELTA CERAMIC HEAD - 104.3210, 347076; BIOLOX DELTA CERAMIC HEAD - 104.3210, 347076; TRINITY CUP - 321.02.348, 360889; TRINITY CUP - 321.02.348, 360889; TRINITY ECIMA LINER - 322.02.632, 372791; TRINITY ECIMA LINER - 322.02.632, 372791; TRINITY SCREW - 321.030, 371508; TRINITY SCREW - 321.030, 371508; BIOLOX DELTA CERAMIC HEAD - 104.3210, 347076; TRINITY CUP - 321.02.348, 360889; TRINITY ECIMA LINER - 322.02.632, 372791; TRINITY SCREW - 321.030, 371508
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR