MAUDE Adverse Event Report: CORIN LTD CORMET RESURFACING; METAL ON METAL RE-SURFACING

Model Number 576-04-344

Device Problem Insufficient Information (3190)

Patient Problems Urinary Tract Infection (2120); Fluid Discharge (2686)

Event Date 05/19/2014

Event Type  Injury  

Event Description

Cormet revision, 6 years & 8 months.Due to kidney infection and fluid build-up in the hip.

Manufacturer Narrative

(b)(4) initial report.Device details, patient medical history, post primary and pre-revision x-rays, explant and reason for revision have been requested in order to progress with the investigation.Device manufacturing records to be reviewed for the femoral head and acetabular cup components.

• Brand Name: CORMET RESURFACING
• Type of Device: METAL ON METAL RE-SURFACING
• Manufacturer (Section D): CORIN LTD; the corinium centre; cirencester, gloucestershire GL7 1YJ; UK GL7 1YJ
• Manufacturer Contact: lucinda gerber ; the corinium centre; cirencester, gloucestershire ; 9774469
• MDR Report Key: 4407480
• MDR Text Key: 5431671
• Report Number: 9614209-2014-00092
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 576-04-344
• Device Lot Number: LAEY
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization