MAUDE Adverse Event Report: DEPUYT ORTHOPAEDICS, INC. SMARTSET GMV GENTAMICIN BONE CEMENT 40 G; BONE CEMENT, ANTIBIOTIC

Model Number 545050501

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 05/01/2016

Event Type  Injury  

Event Description

The reporter states that the patient began experiencing issues of severe pain and inability to bear weight on right leg in (b)(6) 2016.The reporter states that the patient underwent a revision surgery in late (b)(6).The reporter states that the surgeon notes from the surgery stated that both the femoral tray and the tibial tray were loose.

• Brand Name: SMARTSET GMV GENTAMICIN BONE CEMENT 40 G
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): DEPUYT ORTHOPAEDICS, INC. ; warsaw IN
• MDR Report Key: 6728214
• MDR Text Key: 80651670
• Report Number: MW5071094
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/19/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 545050501
• Device Lot Number: 7807552
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 109