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

Model Number NOT PROVIDED

Device Problem Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 04/27/2016

Event Type  No Answer Provided  

Manufacturer Narrative

(b)(4).There is no indication at this time that a revision has occurred.Additional information 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

Patient had a cormet hip replacement in 2010.The patient started experiencing squeaking and crunching and now suffers with lower back pain.The patient saw a surgeon on (b)(6) who has advised for the devices to be revised.At this time, there is no indication that a revision has occurred.

Manufacturer Narrative

(b)(4) final report.Corin have received no information at this point to indicate that a revision has taken place.Additional information was requested in order to progress with this investigation, however, this was not received 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.Based on the above, corin now consider this case closed.However, should additional information be provided this case may be re-opened for further investigation.

Event Description

Patient had a cormet hip replacement in 2010.The patient started experiencing squeaking and crunching and now suffers with lower back pain.The patient saw a surgeon on (b)(6) who has advised for the devices to be revised.At this time there is no indication that a revision has occurred.

• 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: 5855975
• MDR Text Key: 51443508
• Report Number: 9614209-2016-00116
• 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,Followup
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• 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
• Date Manufacturer Received: 05/19/2016
• 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): Other