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

Model Number 179.250B

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Code Available (3191)

Event Date 08/21/2014

Event Type  Injury  

Event Description

Cormet revision after 5 years 4 months due to cobalt-chromium levels.

Manufacturer Narrative

(b)(4).Initial report.Device details, patient medical history, post primary and pre-revision x-rays, explant and reason for revision have been requested in order to progress with the investigation.Device manufacturing records to be reviewed.Please note: this report is filed with the fda due to an 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.

• Brand Name: CORMET
• Type of Device: HIP RESURFACING PROSTHESIS
• Manufacturer (Section D): CORIN LTD.; the corinium centre; cirencester, gloucestershire GL7 1YJ; UK GL7 1YJ
• Manufacturer Contact: adrienne day ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ ; 1286659866
• MDR Report Key: 4117955
• MDR Text Key: 4702255
• Report Number: 9614209-2014-00079
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P050016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 179.250B
• Device Lot Number: MVPQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2014
• 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: LOT MDJR; ASSOCIATED CORMET RESURFACING HEAD: 480.044B
• Patient Outcome(s): Required Intervention