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

Model Number 321.03.350

Device Problem Mechanical Problem (1384)

Patient Problem Joint Dislocation (2374)

Event Date 03/29/2022

Event Type  Injury  

Manufacturer Narrative

Per (b)(4) initial report.The reporter provided additional information including x-rays, operative notes, intervention notes and hospitalization notes.Conclusion of their review will be provided 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 filled 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 occured 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 after approximatively 2 months due to dislocation.

Manufacturer Narrative

Per 5043 final report: the reporter provided additional information including operative notes, intervention notes and hospitalization notes.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 investigation, the patient was revised due to recurrent dislocations.And it was confirmed that the last dislocation was preceded by a trauma (fall of the patient).Thus, the root cause of the reported dislocation is due to the fall of the patient.Therefore, this case is now considered closed.Please note: this report is filled 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 occured 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 after approximatively 2 months 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: 15368360
• MDR Text Key: 299354950
• Report Number: 9614209-2022-00094
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122305
• 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: 10/19/2022

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 Model Number: 321.03.350
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 489253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2021
• 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: BIOLOX DELTA MOD HEAD 104.3605 LOT 494508; BIOLOX DELTA MOD HEAD 104.3605 LOT 494508; TRINITY ECIMA LINER 322.03.636 LOT 494702; TRINITY ECIMA LINER 322.03.636 LOT 494702
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female