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

Model Number 322.05.636

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Joint Dislocation (2374)

Event Date 10/14/2022

Event Type  Injury  

Event Description

Trinity dual mobility revision after approximately 1 year and 9 months due to dislocation.It is currently unknown which of the devices were revised.

Manufacturer Narrative

Per -5145 initial report.Additional information including post primary and pre revision x-rays, operative notes, patient details, what the patient was doing at the time of the dislocation, whether the patient followed correct post-op protocol, whether the patient experienced any slips or falls post primary surgery 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.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.

Manufacturer Narrative

Per -5145 final report.Please note: the device details provided in the initial report were incorrect.The reporter provided the correct device details on 24 oct 2022 and thus they have been corrected in this final report.Additional information including post primary and pre revision x-rays, operative notes, patient details, what the patient was doing at the time of the dislocation, whether the patient followed correct post-op protocol, whether the patient experienced any slips or falls post primary surgery 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 and thus the scope of this investigation was limited.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.It was found that 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 reported dislocation could not be determined.Therefore, this case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation.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

Trinity revision of the cup, ecima liner and 2 screws after approximately 1 year and 9 months due to dislocation.A non-corin head was also revised.Please note: the original device details for this event were reported incorrectly.The device details have therefore, been corrected in this final report.

• 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
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 15657518
• MDR Text Key: 302251899
• Report Number: 9614209-2022-00115
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111481
• 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: 01/13/2023

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 Model Number: 322.05.636
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 458052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 10/24/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2020
• 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: TRINITY CUP: 321.05.360, 452319; TRINITY CUP: 321.05.360, 452319; TRINITY DM COCR LINER: 321.05.540, 456989; TRINITY SCREW: 321.040, 464093; TRINITY SCREW: 321.040, 464093; TRINITY SCREW: 321.050, 456109; TRINITY SCREW: 321.050, 456109
• Patient Outcome(s): Hospitalization; Required Intervention