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

Model Number 179.250B

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Reaction (2414); No Code Available (3191)

Event Date 10/12/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report: additional information, including patient medical history, reason for revision, post primary and pre revision x-rays and the explants have been requested in order to progress with this investigation, and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details have been provided and the relevant device manufacturing records have been retrieved and reviewed, it was found that the parts associated with these records conformed to material and dimensional specification when manufactured.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 due to metal-on-metal reaction and acetabular loosening.

Manufacturer Narrative

(b)(4).Final report.Additional information, including patient notes, post primary and pre revision x-rays, explant and reason for revision were requested in order to progress with this investigation.It was confirmed that the explants were not available for return to corin.The relevant device manufacturing records have been retrieved and reviewed and it was found that the parts associated with the report conformed to material and dimensional specification when manufactured.The corin cormet and optimom devices had been coupled with the a non-corin taper adapter sleeve.At this time it cannot be determined if these devices may have caused or contributed to the patient's experience.Corin considers this case closed but can be re-opened should further information be provided.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 due to metal on metal reaction and acetabular loosening.

• 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 ; 1285659866
• MDR Report Key: 5846489
• MDR Text Key: 51170439
• Report Number: 9614209-2016-00004
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2016

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: 08/31/2009
• Device Model Number: 179.250B
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: ICYQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2015
• Initial Date FDA Received: 08/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2004
• 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