SMARTSET MV

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-26 for SMARTSET MV manufactured by Depuy.

Event Text Entries

[19730442] The reporter had a knee replacement in 2009. Right after the implant, she started to experience pain. She went back to (b)(6) where she got the implant, and was told to give it time for her knee to heal. She continues to experience pain, swollen knees, and redness at the implant site, she went back to (b)(6) but did not get any help. She later got in touch with another doctor through (b)(6) who declared the device as loose and she should either have it corrected or explanted. She stopped working because of pain and discomfort. She takes a lot of pain medication but nothing helps. She fell a couple of times because the implant is unstable because it wobbles. Component implanted depuy pfc sigma non-porus cruciate substituting femoral. Component size 1. 5 white cement tibial base plate cobalt chrome size 2. Posterior stabilized polyethylene tibial insert size 2 by 8mm 3 peg round dome patella 32 mm.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5033123
• MDR Report Key: 3493715
• Date Received: 2013-11-26
• Date of Report: 2013-11-26
• Date of Event: 2009-01-01
• Date Added to Maude: 2013-12-02
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: SMARTSET MV
• Generic Name: BONE CEMENT
• Product Code: LOD
• Date Received: 2013-11-26
• Lot Number: 2946615
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEPUY

Device Sequence Number: 2

• Brand Name: KNEE XSM 32MM PART ROUND/DOME
• Generic Name: DOME PATELLA
• Product Code: HTG
• Date Received: 2013-11-26
• Lot Number: 30000752
• ID Number: LOG 93616
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: DEPUY

Device Sequence Number: 3

• Brand Name: TRAY SIGMA MODULAR TIBIA SIZE 2
• Generic Name: MODULAR TIBIA
• Product Code: JWH
• Date Received: 2013-11-26
• Lot Number: 2990627
• ID Number: LOG 63616
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: DEPUY

Device Sequence Number: 4

• Brand Name: SIGMA POSTERIOR STABILIZED FEMUR
• Generic Name: STABILIZED FEMUR
• Product Code: JWH
• Date Received: 2013-11-26
• Lot Number: CK7RN4
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: DEPUY

Device Sequence Number: 5

• Brand Name: INSERT KNEE 2 TRIAL 96-1420A 8.0MM DEPUY
• Generic Name: KNEE TRIAL
• Product Code: LXH
• Date Received: 2013-11-26
• Lot Number: B87GK4000
• ID Number: LOG 93616
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: DEPUY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2013-11-26