MAUDE Adverse Event Report: CORIN MEDICAL TRINITY; ACETABULAR HIP SYSTEM,

Model Number 104.3205

Device Problem Mechanical Problem (1384)

Patient Problem Joint Dislocation (2374)

Event Date 08/24/2022

Event Type  Injury  

Event Description

Trinity revision of ceramic head & ecima liner after approximately 1 month due to dislocation.

Manufacturer Narrative

Per (b)(4) - fda initial report.Additional information, including x-rays, operative notes, patient medical history, activity level, if the patient experienced any trauma prior to the revision and an update following the 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 devices 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 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.

Manufacturer Narrative

Per 5027 - fda final report additional information, including x-rays and operative notes has been requested in order to progress with the investigation of this event, however this information could not be provided.The devices are not available for examination, as probably discarded by the hospital.The appropriate devices details have been provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specifications at the time of manufacture.Based on the above, the root cause of this event 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.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.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 ceramic head & ecima liner after approximately 1 month due to dislocation.

• Brand Name: TRINITY
• Type of Device: ACETABULAR HIP SYSTEM,
• 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: 15335993
• MDR Text Key: 299064211
• Report Number: 9614209-2022-00089
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K103120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

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: 104.3205
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 506795
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 08/25/2022
• Supplement Dates FDA Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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: METAFIX STEM: 579.0104, 493502; METAFIX STEM: 579.0104, 493502; TRINITY BONE SCREW: 321.030, 500726; TRINITY BONE SCREW: 321.030, 500726; TRINITY CUP: 321.03.350, 495553; TRINITY CUP: 321.03.350, 495553; TRINTY ECIMA LINER: 322.03.932, 495582; TRINTY ECIMA LINER: 322.03.932, 495582
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 100 KG