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

Model Number 179.254B

Device Problem Insufficient Information (3190)

Patient Problem Toxicity (2333)

Event Date 07/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The appropriate device details have been provided and the relevant device manufacturing records will be retrieved and reviewed.The explanted devices have been received at corin and will be examined.The results of this 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 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 5 months due to metallosis.

Manufacturer Narrative

(b)(4) final report.Operative notes, patient x-rays and the explanted devices were provided to aid the investigation and were reviewed at corin.The appropriate device details were provided and the relevant device manufacturing records were identified and reviewed.It was found that all parts associated with these records conformed to material and dimensional specification when manufactured.The explanted devices were returned for examination.The examination of the returned explants could not identify a specific reason for revision, any obvious failure modes or abnormal device characteristics.The corin devices were coupled with a taper conversion sleeve (manufacturer unknown), which exhibited evidence of corrosion inside it.Based on this, it cannot be determined whether the corin cormet devices caused or contributed to the patients experience and 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 5 months due to metallosis.

• Brand Name: CORMET
• Type of Device: HIP RESURFACING 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: 5913850
• MDR Text Key: 53487197
• Report Number: 9614209-2016-00144
• 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: 10/13/2016

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 Model Number: 179.254B
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: HKWR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 08/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2004
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR