MAUDE Adverse Event Report: CORIN, LTD. CORMET RESURFACING HIP SYSTEM

Model Number 479.248B

Device Problem Premature system activation (1486)

Patient Problem No Information (3190)

Event Date 05/29/2014

Event Type  Injury  

Event Description

Revision of cormet cup after 5 years 2 months and associated cormet optimom head after 5 years 1 month.

Manufacturer Narrative

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 will be reviewed.This event is reported to the fda due to the incident experienced to a device that is similar to a medical device that is placed on the market in the usa.However, this was coupled with a thr with a large diameter mom head which is not cleared for sale in the usa (incident was outside of the usa).

• Brand Name: CORMET RESURFACING HIP SYSTEM
• Type of Device: RESURFACING HIP SYSTEM
• Manufacturer (Section D): CORIN, LTD.; the corinium centre; cirencester, gloucestershire GL7 1YJ; UK GL7 1YJ
• Manufacturer Contact: lucinda gerber ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ ; 1285659866
• MDR Report Key: 4951588
• MDR Text Key: 6037332
• Report Number: 9614209-2015-00038
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P050016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Type of Report: Initial
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Model Number: 479.248B
• Device Catalogue Number: 479.248B
• Device Lot Number: LTNR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2008
• 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 LTGN; ASSOCIATED OPTIMOM HEAD (B)(4),
• Patient Outcome(s): Hospitalization; Required Intervention