MAUDE Adverse Event Report: CORIN LTD. UNIGLIDE; UNICONDYLAR KNEE PROSTHESIS

Model Number 515.0400

Device Problems Loose or Intermittent Connection (1371); Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 08/13/2014

Event Type  Injury  

Event Description

Uniglide implant revised to a tkr after 7 years 10 months due to polywear with bearing, dislocation and metallosis and aseptic loosening.

Manufacturer Narrative

Cnl fb-54 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.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
• Type of Device: UNICONDYLAR KNEE PROSTHESIS
• 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 ; 1285884757
• MDR Report Key: 4177719
• MDR Text Key: 5021465
• Report Number: 9614209-2014-00087
• 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: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2011
• Device Model Number: 515.0400
• Device Lot Number: KEND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2006
• 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: ASSOCIATED AMC UNIGLIDE TIBIA PLATE 524.0700; LOT HWWZ; ASSOCIATED UNIGLIDE TIBIAL INSERT 530.0406; LOT HVUX
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR