MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SIGMA TIBIAL INSERT FIXED BEARING ; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL

Lot Number 355414,8076875,8097031,8107693

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 08/24/2015

Event Type  Injury  

Event Description

I had a left total knee replacement on (b)(6) 2015.Shortly afterwards (within a year) i started experiencing pain in my knee.After repeated visits to the dr, it was determined that i would need a knee revision on the lower component as it had caused damage/ chipping of my tibia under the component due to slippage.I had the revision on (b)(6) of 2017.Within 6 months i was having severe pain in my calf area that wouldn't go away.It would come and go in severity, feeling like my leg was going to break.Again it was determined that yet another revision would need to be done.The component had failed to adhere to the cement they used and was now tilted with the top angled towards the front of my leg and the bottom pressing against the back of my tibia.I will undergo my third surgery within 4 years within 4 years on my left leg on monday, (b)(6) 2019.The components used in both previous surgeries were made by depuy / depuy, model is stigma.Had to have left knee revision surgery to remove and replace a failed lower component.This component has also failed and now requires another surgery to replace all components on (b)(6) 2019.F/u visit on (b)(6) 2019 significant loosening of tibial component.Suggest replacement of all components with those from a different mfr.Mbt revision.Fda safety report ids# (b)(4).

• Brand Name: SIGMA TIBIAL INSERT FIXED BEARING
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 9233912
• MDR Text Key: 164082787
• Report Number: MW5090613
• Device Sequence Number: 1
• Product Code: JWH
• 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
• Type of Report: Initial
• Report Date: 10/22/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 355414,8076875,8097031,8107693
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 55 YR
• Patient Weight: 122