MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. CMW 3 BONE CEMENT 40G

Model Number CMW3

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Event Description

In (b)(6) of 2010 first knee replacement.Dr.(b)(6) surgeon.Implant depuy pfc sigma with cmw 3.Failed immediately.Complained of knee pain that never resolved.X rays show lucency, had a back surgery because of right leg.Treated with opiate medications long term.(b)(6) clinical notes clearly state potentially loosening implant never advised.2011 lost job, lost house, career irreparably damaged due to unresolved knee failure.2012 on disability.Lost salary currently over (b)(6).2018 point of discovery dr.(b)(6) states to my wife ¿i just lifted the parts out of his body¿.Knee revision completed walked out of hospital next day and have been tapering off pain medication since.I am now off my cane.It is the first time in 10 years.Last week i saw a commercial for knee failure and i realized we had cause.Sincerely dr.(b)(6) stated to me that he doesn¿t get involved with failures or reporting.Is it not the surgeon¿s responsibility to submit adverse events? fda safety report id # (b)(4).

• Brand Name: CMW 3 BONE CEMENT 40G
• Type of Device: BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 9610730
• MDR Text Key: 176014513
• Report Number: MW5092358
• Device Sequence Number: 1
• Product Code: LOD
• 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: 01/16/2020

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?: Yes
• Device Operator: No Information
• Device Model Number: CMW3
• Device Catalogue Number: 2012-05
• Device Lot Number: 2922894
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 52 YR
• Patient Weight: 88