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

Model Number NOT PROVIDED

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Toxicity (2333)

Event Date 03/20/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.This initial report is being submitted now as it was erroneously submitted as a follow-up in error.Additional information, including device details, has been requested and, if received, will be provided in the supplemental report upon completion of the investigation.Device manufacturing records will be reviewed upon receipt of appropriate device details.Please note: this report is filed with the fda due to an event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside 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 the event.

Event Description

It is alleged that the patient suffered from high levels of metal in the blood and pain following implantation of cormet resurfacing implants in 2006 and, therefore, the patient underwent a further operation in 2014.

• 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; gloucestershire, GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: lucinda gerber ; the corinium centre; cirencester; gloucestershire, GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 10133127
• MDR Text Key: 194534077
• Report Number: 9614209-2015-00059
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/05/2015

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: NOT PROVIDED
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: NOT PROVIDED
• Initial Date Manufacturer Received: 10/16/2015
• Initial Date FDA Received: 06/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization