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

Model Number NOT PROVIDED

Device Problems Device Slipped (1584); Patient-Device Incompatibility (2682)

Patient Problems Loss of Range of Motion (2032); Toxicity (2333)

Event Date 03/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Please note: this mdr was originally filed on 03 jun 2016 to an esubmissions test account.Additional information, including device details have 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 reviewed upon receipt of the appropriate device details.

Event Description

An fda medwatch report (ref.Mw5061405) was received at corin usa regarding a cormet revision after approximately 12 years due to loosening of the acetabular component generating metallosi and immobility for the patient.

Manufacturer Narrative

(b)(4) final report.Additional information, including device details were requested in order to progress with this investigation, however, these were not received.The relevant device manufacturing records could not be identified as the appropriate device details were not provided.Corin considers this case closed, but should further information become available, the case can be reopened and investigated as appropriate.

Event Description

An fda medwatch report (ref.Mw5061405) was received at corin usa regarding a cormet revision after approximately 12 years due to loosening of the acetabular component generating metallosis and immobility for the patient.

• Brand Name: CORMET
• Type of Device: HIP RESURFACING PROSTHESIS
• 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: 5855979
• MDR Text Key: 51446494
• Report Number: 9614209-2016-00113
• 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: 12/16/2016

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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention