MAUDE Adverse Event Report: CONFORMIS, INC. IUNI G2; UNICONDYLAR KNEE REPLACEMEMENT SYSTEM

Catalog Number M5722INT0600220

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 10/01/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient fell post-operatively and has a dislocated poly insert.A revision surgery is planned to exchange the poly insert.Review of the device history record indicates the device was manufactured to specification.

Event Description

It was reported that the patient fell post-operatively and has a dislocated poly insert.A revision surgery is planned to exchange the poly insert.

Manufacturer Narrative

It was reported that the patient fell post-operatively and has a dislocated poly insert.Revision surgery occurred to exchange the poly insert.The insert was not dislocated as originally reported.It was reported that the patient had pain and swelling because of the fall.The poly insert was exchanged.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that the patient fell post-operatively and has a dislocated poly insert.Revision surgery occurred to exchange the poly insert.The insert was not dislocated as originally reported.It was reported that the patient had pain and swelling because of the fall.The poly insert was exchanged.

Manufacturer Narrative

It was reported that the patient fell post-operatively and has a dislocated poly insert.Revision surgery occurred to exchange the poly inserts.The insert was not dislocated as originally reported.It was reported that the patient had swelling because of the fall.The poly inserts were exchanged.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that the patient fell post-operatively and has a dislocated poly insert.Revision surgery occurred to exchange the poly inserts.The insert was not dislocated as originally reported.It was reported that the patient had swelling because of the fall.The poly inserts were exchanged.

• Brand Name: IUNI G2
• Type of Device: UNICONDYLAR KNEE REPLACEMEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• Manufacturer (Section G): CONFORMIS, INC; 600 research drive; wilmington MA 01887
• Manufacturer Contact: karina snow ; 600 technology park drive; billerica, MA 01821 ; 7813459195
• MDR Report Key: 6957467
• MDR Text Key: 89570946
• Report Number: 3004153240-2017-00228
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2017

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: 08/31/2016
• Device Catalogue Number: M5722INT0600220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 10/18/2017
• Supplement Dates Manufacturer Received: 10/05/2017; 10/05/2017
• Supplement Dates FDA Received: 11/28/2017; 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2016
• 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: 58 YR