MAUDE Adverse Event Report: CORIN MEDICAL TRINITY; ACETABULAR HIP SYSTEM WITH ECIMA LINERS

Model Number 322.03.932

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Joint Dislocation (2374); Muscle/Tendon Damage (4532)

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

Per -(b)(4) initial report.It was reported that the patient had a dislocation related to trauma, they fell over and ruptured the external rotators.Additional information, including post primary and pre revision x-rays, operative notes, patient age, patient activity level, patient medical history and an update on the patient post revision 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

Trinity revision of the ceramic head and ecima liner after approximately 3 years and 7 months due to dislocation.

Event Description

Trinity revision of the ceramic head and ecima liner after approximately 3 years and 7 months due to dislocation.

Manufacturer Narrative

Per -4197 final report.It was reported that the patient had a dislocation related to trauma, they fell over and ruptured the external rotators.Additional information, including post primary and pre revision x-rays, operative notes, patient age, patient activity level, patient medical history and an update on the patient post revision was requested in order to progress with the investigation of this event, however, this information could not be provided.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All 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 it has been concluded that the root cause of the reported dislocation was the patient falling and damaging soft tissues.Therefore, 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.

• Brand Name: TRINITY
• Type of Device: ACETABULAR HIP SYSTEM WITH ECIMA LINERS
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 12647504
• MDR Text Key: 277092653
• Report Number: 9614209-2021-00123
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K111481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: 322.03.932
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 283330
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOLOX DELTA CERAMIC HEAD: 104.3200, 363684.; BIOLOX DELTA CERAMIC HEAD: 104.3200, 363684.; TRIFIT TS STEM: 694.0004, 312828.; TRIFIT TS STEM: 694.0004, 312828.; TRINITY CUP: 321.03.350, 356800.; TRINITY CUP: 321.03.350, 356800.; TRINITY SCREW: 321.025, 359583.; TRINITY SCREW: 321.025, 359583.
• Patient Outcome(s): Hospitalization; Required Intervention