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

Model Number 179.056B

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 09/18/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.The relevant device manufacturing records for the three reported devices have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification.It is not know at this time whether the reported devices are available to be examined, if they do become available the results of this examination will be provided in a supplemental report upon completion of the investigation.Please note: this report is filed with the fda due to an adverse event that occurred with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.

Event Description

Cormet revision after approximately 7 years.The primary surgery was completed in 2007 and 2008.

Manufacturer Narrative

(b)(4) final report.Additional information, including the return of the explanted devices was requested in order to progress with this investigation.However, these were not provided and therefore there was only very limited information available for the investigation.The relevant device manufacturing records for the three reported devices have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification.Based on this, it cannot be determined whether or not the corin cormet devices caused or contributed to the patients experience.Corin now consider this case closed, however, should the explanted devices become available for examination, or if further information is provided, this case may be re-opened for further investigation.Please note: this report is filed with the fda due to an adverse event that occurred 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 MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: lucinda gerber ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ ; 1285659866
• MDR Report Key: 5949388
• MDR Text Key: 54673674
• Report Number: 9614209-2016-00151
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P050016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2016

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: 03/31/2010
• Device Model Number: 179.056B
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: IRXQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2005
• 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 CUP 179.262B, JWHR; CORNET HEAD 179.056B, IPQZ
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR