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

Model Number 579.0105

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 09/25/2022

Event Type  Injury  

Event Description

Revision after approximatively 2 days due to poor implantation of the stem during the first surgery.

Manufacturer Narrative

Per (b)(4) - fda initial report.Additional information including operative notes and an update of 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 places on the market in the usa, however, this event occured 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

Revision after approximatively 2 days due to poor implantation of the stem during the first surgery.

Manufacturer Narrative

Per 5123 - fda final report.X-rays, operative notes and update of the patient post revision were not available.The appropriate device details were provided, and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specifications at the time of manufacture.It was reported that the stem was placed through the femur during the primary surgery.This was a primary surgeon error, broaching and implanting the stem through the back of and then outside of the femur.Based on the above, the root cause is external thus, corin consider this case closed.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those places on the market in the usa, however, this event occured 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: dardan uka ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 15559849
• MDR Text Key: 301346886
• Report Number: 9614209-2022-00105
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K153381
• 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: 10/26/2022

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 Expiration Date: 02/07/2024
• Device Model Number: 579.0105
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 409927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/01/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 10/01/2022
• Supplement Dates FDA Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2019
• 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: TRINITY COCR LINER 321.04.540 LOT 504708; TRINITY COCR LINER 321.04.540 LOT 504708; TRINITY COCR MOD HEAD E321.128 LOT 505335; TRINITY COCR MOD HEAD E321.128 LOT 505335; TRINITY CUP 321.04.354 LOT 503706; TRINITY CUP 321.04.354 LOT 503706; TRINITY ECIMA INSERT 325.04.042 LOT 505130; TRINITY ECIMA INSERT 325.04.042 LOT 505130
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male