MAUDE Adverse Event Report: CORIN LTD TRINITY; ACETABULAR HIP SYSTEM

Model Number 321.02.348

Device Problem Unintended Movement (3026)

Patient Problem Inflammation (1932)

Event Date 01/09/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information including; patient activity level, weight and medical history, did the patient follow correct post-op protocol, an update on the patient post revision, how long after primary surgery did the issues start, did the patient experience any slips / falls or any other trauma post primary surgery, post primary x-rays & was the cup positioning changed during the revision surgery 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.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 & minihip revision after approximately 8 years 6 months due to tendonitis and secondary to mild retroversion of acetabular cup.

Manufacturer Narrative

(b)(4).Final report additional information including operative notes, patient activity level , did the patient follow the correct post-op protocol and an update on the patient post revision, how long after primary surgery did the issues start, did the patient experience any slips / falls or any other trauma post primary surgery, post primary x-rays and was the cup positioning changed during the revision surgery was requested in order to progress with the investigation of this event.However, only some of this information could 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 were cleaned and packaged to the correct specifications at the time of manufacture.Based on clinical notes provided by the reporter it can be confirmed from a spec ct scan there was mild retroversion of the acetabular cup, which may explain the patients discomfort.However, original surgery notes do not record the position of the cup.Thus, the root cause of the cup mis-positioning cannot be confirmed.It is unknown if it was implanted in this position or if it has migrated post primary.If more information is provided this file may be re-opened for further investigation.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
• Manufacturer (Section D): CORIN LTD; the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; 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: 16252886
• MDR Text Key: 308252537
• Report Number: 9614209-2023-00152
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K093472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

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 Expiration Date: 04/01/2019
• Device Model Number: 321.02.348
• Device Lot Number: 280788
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/10/2023
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 01/27/2023
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BILOX DELTA CERAMIC HEAD 104.3200, 286822; MINIHIP STEM 580.0001, 266598; TRINITY ECIMA LINER 322.02.932, 287450; TRINITY ECIMA LINER 322.02.932, 287450
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 47 KG