MAUDE Adverse Event Report: CORIN, LTD. UNIGLIDE KNEE SYSTEM; FIXED BEARING UNICONDYLAR KNEE

Model Number 525.1707

Device Problem Insufficient Information (3190)

Patient Problems Rheumatoid Arthritis (1724); Pain (1994); Toxicity (2333)

Event Date 07/11/2014

Event Type  Injury  

Event Description

Revision of fixed uniglide knee to a tkr due to pain, metallosis and progression of rheumatoid arthritis.

Manufacturer Narrative

(b)(4) final report.The explanted devices and x-rays were not available for review and analysis.Additional clinic notes have been provided in order to progress the investigation.Available device manufacturing records were reviewed and it was found that the part associated with the records conformed to material and dimensional specification.Should additional info become available it will be reported in a supplemental report upon completion of the investigation.Please note: this report is filed with the fda due to an 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.

• Brand Name: UNIGLIDE KNEE SYSTEM
• Type of Device: FIXED BEARING UNICONDYLAR KNEE
• Manufacturer (Section D): CORIN, LTD.; the corinium centre; cirencester, gloucestershire GL7 1YJ; UK GL7 1YJ
• Manufacturer Contact: adrienne day ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ ; 285884757
• MDR Report Key: 4531870
• MDR Text Key: 5359590
• Report Number: 9614209-2014-00097
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Model Number: 525.1707
• Device Lot Number: MVCI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2009
• 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
• Treatment: UNIGLIDE TIBIAL COMPONENT,; MODEL: 515.0400, LOT: MSFJ
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR