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

Model Number 322.03.936

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 10/04/2021

Event Type  Injury  

Manufacturer Narrative

Per -(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes, patient medical history and an update on the patient post 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 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.

Event Description

Trinity revision of the ecima liner and ceramic head after approximately 8 weeks due to infection.

Manufacturer Narrative

Per (b)(4) - final report.Additional information, including x-rays, operative notes, patient medical history and an update on the patient post revision was requested in order to progress with the investigation of this event, however, apart from a pre and post primary surgery, this information could not be provided.The appropriate device details were provided and the relevant manufacturing and sterilisation records have been identified and reviewed.These devices were manufactured, packaged and sterilised to the correct specifications at the time of manufacture.The sterilization method and sterile barrier system used to package trinity devices have a long history of safe and effective use at corin for a wide range of orthopaedic devices and has been validated in accordance with the relevant standards.Infection is a known complication with any invasive surgery.Based on the above, no further investigation can be conducted and the root cause of the infection could not be determined, therefore, this case is now considered closed.However, should any additional information be provided then this case may be reopened for further investigation.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 the ecima liner and ceramic head after approximately 8 weeks due to infection.

• Brand Name: TRINITY
• Type of Device: ACETABULAR HIP SYSTEM WITH ECIMA LINERS
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester, GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium center; cirencester, GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: marie-anne euzen ; the corinium center; cirencester, GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 12671069
• MDR Text Key: 277604123
• Report Number: 9614209-2021-00125
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K111481
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 322.03.936
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 472223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• 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 CERAMIC HEAD: 104.3605, 455524; BIOLOX DELTA MODULAR HEAD: PART 1043605 LOT 455524; BIOLOX DELTA CERAMIC HEAD: 104.3605, 455524
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female