MAUDE Adverse Event Report: CORIN LTD CORMET; HIP RESURFACING PROSTHESIS

Model Number UNKNOWN

Device Problem Loss of Osseointegration (2408)

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

Event Date 12/28/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information including part nos.And lot codes, post primary and pre revision x-rays, operative notes, date of primary surgery, patient details, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary surgery 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 this event.

Event Description

Cormet revision (scheduled for (b)(6) 2023).Primary surgery was in 2009 where a 42mm cormet head and 48mm cormet cup were implanted.Revision required due to loosening of the cup.

• Brand Name: CORMET
• Type of Device: HIP RESURFACING PROSTHESIS
• 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 Y; UK GL7 1Y
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester; gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 18454486
• MDR Text Key: 332259758
• Report Number: 9614209-2024-00280
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P050016
• 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
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/12/2023
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: CORMET RESURFACING HEAD: DEVICE DETAILS UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention