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

Model Number 694.0003

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2019

Event Type  Injury  

Manufacturer Narrative

Per -2635 initial report: upon receipt of the appropriate device details the relevant device manufacturing records shall be identified and reviewed.Details of this review will be provided in a supplemental report upon completion of the investigation.Please note: this report is filed with the fda due to an 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 after approximately 1.5 months due to periprosthetic fracture.

Manufacturer Narrative

Per -2635 final report.It was reported that the periprosthetic fracture occurred when the patient jumped out of their truck.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.As this event was the result of the patient jumping out of their truck, no further investigation is required, and this case is now considered closed.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.

Event Description

Trifit ts / trinity revision of the stem and ceramic head after approximately 1.5 months due to periprosthetic fracture.

• Brand Name: TRIFIT TS
• Type of Device: HIP STEM
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 9495124
• MDR Text Key: 176767411
• Report Number: 9614209-2019-00136
• 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: 09/08/2020

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: 01/13/2023
• Device Model Number: 694.0003
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 379987
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 12/03/2019
• Supplement Dates FDA Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOLOX CERAMIC HEAD - 104.3610, 428943.; BIOLOX CERAMIC HEAD - 104.3610, LOT UNKNOWN.; BIOLOX CERAMIC LINER - 321.03.436, 438219.; BIOLOX CERAMIC LINER - 321.03.436, 438219.; TRINITY CUP - 321.03.352, 394197.; TRINITY CUP - 321.03.352, 394197.
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 48 YR