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.

Manufacturer Narrative

(b)(4).Final report.Additional information including revised 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.No further information was provided.The device details for the primary surgery were identified.However no information on the revision was found, so it is unknown which devices are loose and were revised.The manufacturing records of all the devices implanted at the primary surgery were reviewed: finished parts conformed to material and dimensional specifications at the time of manufacture.Based on this, no further investigation can be performed.The case is now considered closed.If further information is provided, the case may be reopened.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; TRIFIT TS STEM694.1001 LOT 344256; TRINITY CERAMIC HEAD 104.2800 LOT 437241; TRINITY DUAL MOBILITY INSERT 325.03.040 LOT 411186; TRINITY LINER 321.03.536 LOT 411359; TRINITY SCREW 321.020 LOT 418431
• Patient Outcome(s): Required Intervention; Hospitalization; Disability