MAUDE Adverse Event Report: CORIN MEDICAL METAFIX; CORIN METAFIX HIP STEM

Model Number 579.2005

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

Patient Problem Unspecified Infection (1930)

Event Date 08/31/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information, including 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 identied 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

Metafix / trinity revision of all components after 20 days due to infection.This is the second revision for this patient.

Event Description

Metafix / trinity revision of all components after 20 days due to infection.This is the second revision for this patient.

Manufacturer Narrative

Per 4091 - 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, 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 / metafix 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.

• Brand Name: METAFIX
• Type of Device: CORIN METAFIX HIP STEM
• 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: marie anne euzen ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 12437945
• MDR Text Key: 270787041
• Report Number: 9614209-2021-00109
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K082525
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 579.2005
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 463260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• 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 MODULAR HEAD: 104.3610 LOT 483338; BIOLOX DELTA MODULAR HEAD: 104.3610 LOT 483338; TRINITY CUP: 321.04.358 LOT 462573; TRINITY CUP: 321.04.358 LOT 462573; TRINITY ECIMA LINER: 322.04.636 LOT 480557; TRINITY ECIMA LINER: 322.04.636 LOT 480557
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male