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

Model Number NOT PROVIDED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 11/07/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report additional information, including device details and the return of the explanted devices has 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 relevant device manufacturing records will be retrieved and reviewed upon receipt of the appropriate device details.

Event Description

Cormet revision after approximately 4 years and 10 months due to pain.

Manufacturer Narrative

(b)(4).Additional information, including the device details, patient x-rays and the return of the explanted devices was requested in order to progress with this investigation.However, these were not provided and therefore there was only very limited information available for the investigation.The appropriate device details were not provided and thus the relevant device manufacturing records could not be identified or reviewed.The explanted devices were not returned to corin for examination, therefore, further investigation could not be carried out.Based on this, it cannot be determined whether or not the corin cormet devices caused or contributed to the patients experience.Corin now consider this case closed, however, should the explanted devices become available for examination, or if further information is provided, this case may be re-opened for further investigation.

Event Description

Cormet revision after approximately 4 years and 10 months due to pain.

• 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: 5913818
• MDR Text Key: 53480469
• Report Number: 9614209-2016-00143
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 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: Health Professional
• Device Model Number: NOT PROVIDED
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2016
• Initial Date FDA Received: 08/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/12/2016
• 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
• Patient Age: 61 YR
• Patient Weight: 112