MAUDE Adverse Event Report: CORIN LTD METAFIX; METAFIX FEMORAL STEM

Model Number 579.0006

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2023

Event Type  malfunction  

Event Description

Corin were made aware of a suspected metafix event, however, it was originally unclear what had occurred and whether there had been a device revision.Part nos.Were also not provided and thus it could not be confirmed that the event had involved a corin device.Additional information was requested from the hospital and it was confirmed to corin on (b)(6) 2023 that a patient had required a metafix stem revision due to a fracture of the stem following a fall.The device part no.Was also provided.

Manufacturer Narrative

Additional information, including lot code of the affected stem, part nos.And lot codes of any associated devices, post primary and pre revision x-rays, operatives notes (primary and revision), patient details, whether the patient followed 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, and if received, will be provided in a supplemental report upon completion of the investigation.Upon receipt of the appropriate device details, 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 the event.

• Brand Name: METAFIX
• Type of Device: METAFIX FEMORAL STEM
• 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: 17697063
• MDR Text Key: 322812503
• Report Number: 9614209-2023-00233
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 579.0006
• Device Lot Number: TBC
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/06/2023
• Date Manufacturer Received: 09/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male