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

Model Number 179.246B

Device Problems Degraded (1153); Patient-Device Incompatibility (2682)

Patient Problems Reaction (2414); Metal Related Pathology (4530)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information, including additional x-rays, operative notes, patient details, an update on the patient following the revision, the date of initial implant and return of the explanted devices has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details have been provided.The relevant device manufacturing records will be identified and reviewed.Conclusion of the review will be provided in a supplemental 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.

Event Description

Cormet revision due to adverse soft tissue reaction.Elevated chromium and cobalt ion levels were reported.

Event Description

Cormet revision due to adverse soft tissue reaction.Elevated chromium and cobalt ion levels were reported.

Manufacturer Narrative

Per -3068 final report.Additional information, including, the date of initial implant, additional x rays, patient details, and an update on the patient following the revision was requested in order to progress with the investigation of this event, however, this information was not provided 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 passed inspection.Pre-revision xrays were provided: it is visible that the corin devices were coupled with a taper conversion sleeve (manufacturer unknown) and an off-label stem.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 implanted device.Based on the information provided, no further investigation can be conducted and the rootcause remains unkown.Thus this case is now considered closed.Should any additional information be available, the case will be reopened.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.

• Brand Name: CORMET
• Type of Device: HIP RESURFACING SYSTEM
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester, gl7 1yj ; UK
• MDR Report Key: 10367932
• MDR Text Key: 201845415
• Report Number: 9614209-2020-00059
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2008
• Device Model Number: 179.246B
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 8303/22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORMET HEAD: PART NUMBER E079.740, LOT 09439; CORMET HEAD: PART NUMBER E079.740, LOT 09439
• Patient Outcome(s): Hospitalization; Required Intervention