MAUDE Adverse Event Report: ZIMMER/BIOMET ZIMMER TOTAL KNEE SOLUTION; ZIMMER LPS-FLEX LCCK

Model Number LPS-FLEX TOTAL KNEE SOLUTION

Device Problems Unstable (1667); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problems Pain (1994); Anxiety (2328); No Code Available (3191)

Event Date 09/17/2014

Event Type  Injury  

Event Description

As of this day: (b)(6) 2016: i was seen at (b)(6) hospital; (b)(6), for a strange growth that appeared on the outside of my left implant [zimmer lps-flex].It was the shape of an egg.Staff was out done and could not explain; at that time no xrays had been done.Once the xrays and the ultrasound were done i left.Not wanting to hear the same thing again i left."go see the md that put them in".Dr.(b)(6) of (b)(6) has said there's nothing wrong for two years or more.Since installation of these units there have been nothing but: 24 hour pain, cracking sounds, instability, anxiety, as well as a constant fear of falling and really hurting myself.I still have the product in my possession: yes.The product was damaged before the incident: yes.The damage was repaired prior to the incident: no.The product was modified before the incident: no.Explanation: faulty parts.May we include your report: yes.You may include my report with any attachments on (b)(6).

• Brand Name: ZIMMER TOTAL KNEE SOLUTION
• Type of Device: ZIMMER LPS-FLEX LCCK
• Manufacturer (Section D): ZIMMER/BIOMET
• MDR Report Key: 5903687
• MDR Text Key: 53106952
• Report Number: MW5064337
• Device Sequence Number: 1
• Product Code: MBH
• 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: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: LPS-FLEX TOTAL KNEE SOLUTION
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR