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

Model Number 179.254B

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 11/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information, including operative notes has been requested and if received will be provided in a supplemental report upon completion of this investigation.The explanted devices have been returned to corin and will be reviewed.The appropriate device details have been provided and the relevant device manufacturing records will be retrieved 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 after approximately 11 years and 11 months.The reason for revision was not provided.

Manufacturer Narrative

(b)(4) final report.Additional information, including operative notes were requested, and provided along with a pre revision x-ray and the explanted devices which were reviewed at corin.Examination of the explanted devices did not identify any obvious failure modes or abnormal device characteristics.Both the cormet cup and head exhibited characteristics expected of an implant in use for approximately 12 years.The corin devices were coupled with a taper conversion sleeve (manufacturer unknown).The appropriate device details were provided and the relevant device manufacturing records were identified and reviewed, all parts associated with these records conformed to material and dimensional specification.Based on the above, corin now consider this case closed.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.

Event Description

Cormet revision after approximately 11 years and 11 months due to elevated metal ion levels.

• Brand Name: CORMET
• Type of Device: RESURFACING HIP SYSTEM
• 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, 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: 6192986
• MDR Text Key: 62958273
• Report Number: 9614209-2016-00161
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P050016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2009
• Device Model Number: 179.254B
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 025372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2004
• 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: ASSOCIATED CORMET HEAD, E079.748, 024092
• Patient Outcome(s): Hospitalization; Required Intervention