MAUDE Adverse Event Report: CORIN LTD TRINITY; TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS

Model Number 320.02.346

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Subluxation (4525)

Event Date 07/25/2023

Event Type  Injury  

Manufacturer Narrative

Case-(b)(4) initial report : additional information including; operative notes, post primary and pre revision x-rays, did the patient follow the correct post-op protocol and an update on the patient post revision has been requested 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 revision of cup, ecima liner, ceramic head and bone screw after approximately 1 year 4 months & 3 weeks due to subluxation.

Manufacturer Narrative

Case (b)(4) final report.The explanted devices were not returned for evaluation.The manufacturer has conducted an investigation into this event.All products associated with this event were manufactured, sterilised and packaged to the correct specifications at the time of manufacture.No deviation from the process or non-conformity of product was observed on the manufacturing and sterilisation records of the products involved that would have caused the reported adverse event.The complaint made no indication of any device malfunction or deficiency related to identity, quality, durability, reliability, safety effectiveness or device performance contributing to the adverse event.Based on the available information, the root cause of this event could not be determined, and there is no evidence that device malfunction has caused or contributed to this event.Hence, no remedial, corrective or preventive action was deemed necessary and 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: TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS
• Manufacturer (Section D): CORIN LTD; the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD; 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: 17601442
• MDR Text Key: 321711206
• Report Number: 9614209-2023-00224
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123705
• 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: 02/15/2024

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: 320.02.346
• Device Lot Number: 448819
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/25/2023
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• 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 CERAMIC HEAD 104.3205, 464394; TRINITY BONE SCREW 321.030, 434479; TRINITY ECIMA LINER 322.02.632, 379635
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female