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

Model Number 179.246B

Device Problem Insufficient Information (3190)

Patient Problem Toxicity (2333)

Event Date 06/13/2016

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 returned to corin (b)(4) and will be reviewed.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 8 years and 11 months due to elevated cobalt and chromium levels.

• 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: 5913823
• MDR Text Key: 53488759
• Report Number: 9614209-2016-00146
• 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
• Report Date: 08/30/2016

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: No Information
• Device Model Number: 179.246B
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: KFAO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Initial Date Manufacturer Received: 08/23/2016
• Initial Date FDA Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ASSOCIATED OPTIMOM HEAD, E079.740, KIOP
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR