MAUDE Adverse Event Report: CORIN LTD (UK & FR) TRINITY ACETABULAR HIP SYSTEM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 321.03.350

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/08/2018

Event Type  Injury  

Event Description

Patient has a trifit/trinity right hip replacement.Device became loose and required a revision surgery.Patient reports that he has been on disability ever since.The patient reported this event to fda on (b)(6) 2023: fda report mw5144677.

Manufacturer Narrative

Case-(b)(4) initial report.Additional information including device details, which device became loose, post primary and pre revision x-rays, operative notes (primary and revision), patient activity level and medical history, did the patient experience any trauma, did the patient follow correct post-op protocol, and an update on the patient post revision has been requested in order to progress with the investigation of this event.Conclusions will be provided in a supplemental report.Please note: 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 ACETABULAR HIP SYSTEM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): CORIN LTD (UK & FR); the corinium centre; love lane industrial estate; cirencester GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD (UK & FR); the corinium center; love ln, love lane industrial; cirencester GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium center; love ln, love lane industrial; cirencester GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 17831775
• MDR Text Key: 324432136
• Report Number: 9614209-2023-00243
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2023
• Device Model Number: 321.03.350
• Device Lot Number: 406533
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/27/2023
• Date Manufacturer Received: 09/12/2023
• 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: TRIFIT STEM PART UNKNOWN LOT UNKNOWN
• Patient Outcome(s): Required Intervention; Hospitalization; Disability