MAUDE Adverse Event Report: ZIMMER ZIMMER TOTAL KNEE PROSTHESIS

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Swelling (2091)

Event Date 06/15/2013

Event Type  Injury  

Event Description

Received a zimmer nexgen lps-flex gsf femur, a zimmer nexgen lps-flex size 3 tibia, and a tibial insert- zimmer longevity 10 mm.Being that i had a total knee replacement in my other knee one year earlier, i knew immediately that this recovery was different.I was told not to compare surgeries and to give it time.In the summer of 2015, i had to hold onto anything i could to just walk again, i was told to give it time.The leg is always swollen, it's painful and now in 2017 it has started to bow outward when i walk.This past (b)(6), an x-ray confirmed that everything is loose and i need revision surgery.Was this product recalled prior to my surgeon using?.

• Brand Name: ZIMMER TOTAL KNEE PROSTHESIS
• Type of Device: ZIMMER TOTAL KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER
• MDR Report Key: 6311701
• MDR Text Key: 66931121
• Report Number: MW5067750
• Device Sequence Number: 2
• Product Code: KRO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 02/06/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: METAMUCIL. ; RX MEDS: NONE.
• Patient Outcome(s): Other; Disability
• Patient Age: 62 YR
• Patient Weight: 65