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

Model Number 179.256B

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Toxicity (2333); Metal Related Pathology (4530)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

Per (b)(4).Additional information, including post primary and pre revision x-rays, operative notes, patient details, an update on the patient following revision and the return of the explanted "dveices" has been requested in order to progress with the investigation of this event, and if received, will be provided 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 and 5 months due to reported elevated cobalt and chromium ion levels.

Manufacturer Narrative

Per -2794 final report additional information, including the reason for revision, x-rays, operative notes, patient details, and an update on the patient following the revision was requested in order to progress with the investigation of this event.Blood testing results were provided which show high ions levels.Operative notes from the initial surgery were provided, in which good stability was reported.The appropriate device details have been provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.The explanted devices were returned to corin: the corin devices were coupled with a taper conversion sleeve (manufacturer unknown) and an off-label stem.Examination of the cormet 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 a device implanted for more than 13 years.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: the reason for revision was indicated as "high ions levels" in the initial report.However, no reason for revision was provided.High ion levels were observed in the blood results provided by the reporter.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 13 years and 5 months due to unknown reason.Elevated cobalt and chromium ion levels were reported.

• Brand Name: CORMET
• Type of Device: HIP RESURFACING SYSTEM
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester; cirencester, gl7 1yj GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 9779930
• MDR Text Key: 186404513
• Report Number: 9614209-2020-00025
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

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: 04/01/2011
• Device Model Number: 179.256B
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: JWHP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/03/2020
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORMET HEAD - E079.748, JZAR; CORMET HEAD - E079.748, JZAR
• Patient Outcome(s): Hospitalization; Required Intervention