MAUDE Adverse Event Report: CONFORMIS, INC. IDUO G2; BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM

Catalog Number M5723INT0600220

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

Patient has residual pain behind the patella.Surgery is planned to resurface the patella.The poly insert will be exchanged during the procedure.Review of the device history record indicates that the device was manufactured to specification.

Event Description

Patient has residual pain behind the patella.Surgery is planned to resurface, the patella.The poly insert will be exchanged during the procedure.

Manufacturer Narrative

Patient had pressure in the knee and residual pain behind the patella.Patient was diagnosed with retro patella arthrosis.Surgery occurred to resurface the patella and exchange the poly inserts.Review of the device history record indicates that the device was manufactured to specification.

Event Description

Patient had pressure in the knee and residual pain behind the patella.Patient was diagnosed with retro patella arthrosis.Surgery occurred to resurface the patella and exchange the poly inserts.

• Brand Name: IDUO G2
• Type of Device: BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 28 crosby drive; bedford MA 01730
• Manufacturer Contact: karina snow ; 28 crosby drive; bedford, MA 01730 ; 7813459195
• MDR Report Key: 5152384
• MDR Text Key: 28370746
• Report Number: 3004153240-2015-00194
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 12/16/2015

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: Physician
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: M5723INT0600220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2014
• 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): Required Intervention
• Patient Age: 74 YR