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

Model Number 179.254B

Device Problems Degraded (1153); Material Fragmentation (1261); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Reaction (2414); Test Result (2695); Metal Related Pathology (4530)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information, including pre revision x-rays, patient details and a detailed patient outcome has been requested in order to progress with the investigation of this event, however, it has been confirmed that this information is not available and thus the investigation is limited.Post revision x-rays and the explanted devices have been provided to corin and will be reviewed; details of these reviews will be provided in a supplemental report upon completion of the investigation.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.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 13 years due to reported pain, metallosis and alval reaction.

Manufacturer Narrative

Per -(b)(4) final report.Additional information, including pre-revision x-rays, patient details and a detailed patient outcome was requested in order to progress with the investigation of this event, however, this information is not available and thus our investigation is limited.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.Post-revision x-rays were provided and the explanted devices were returned to corin.Examination of these devices did not present any obvious failure modes or abnormal device characteristics and there were no signs of gross wear on the bearing surfaces of the cormet implants.Both the cormet cup and head exhibited surface characteristics expected of an implant which had been in use for approximately 14 years.The corin devices were coupled with a taper conversion sleeve (manufacturer unknown) and were combined with an off-label stem.Based on the information provided, no further investigation can be conducted and thus this case is now considered closed.Please note: the lot codes of the devices were updated compared to the initial report.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.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

Event Description

Cormet revision after approximately 14 years due to reported pain, metallosis and alval reaction.

• Brand Name: CORMET
• Type of Device: HIP RESURFACING PROSTHESIS
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester; cirencester, gl7 1yj GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 8940222
• MDR Text Key: 157456935
• Report Number: 9614209-2019-00081
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P050016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2009
• Device Model Number: 179.254B
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 30284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Date Manufacturer Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: CORMET HEAD - E079.748, 033425; CORMET HEAD - E079.748, ILRS
• Patient Outcome(s): Hospitalization; Required Intervention