MAUDE Adverse Event Report: CUSTOM JTS DISTAL FEMUR REPLACEMENT IMPLANT; DISTAL FEMUR IMPLANT

Model Number BME18850

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2015

Event Type  Injury  

Event Description

During a custom jts distal femur replacement procedure the surgeon experienced difficulty fitting the rotating hinge tibial component into the tibial baseplate and stem that were in situ.He was unable to get the implant to seat correctly.A second rotating hinge tibial component was used which was implanted without any complication.The second component selected appeared to be shorter than the first component that was used.

• Brand Name: CUSTOM JTS DISTAL FEMUR REPLACEMENT IMPLANT
• Type of Device: DISTAL FEMUR IMPLANT
• MDR Report Key: 4665427
• MDR Text Key: 5683042
• Report Number: 3009991237-2015-00006
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2015,03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/04/2015
• Device Model Number: BME18850
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2015
• Distributor Facility Aware Date: 03/11/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR