MAUDE Adverse Event Report: ZIMMER INC. TRABECULAR METAL TIBIAL TRAY FIXED BEARING SIZE 6

Device Problems Loose or Intermittent Connection (1371); Material Too Rigid or Stiff (1544); Unstable (1667); Noise, Audible (3273)

Patient Problems Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

Event Date 10/06/2015

Event Type  Injury  

Event Description

I had a new replacement on (b)(6) 2015 after waiting an appropriate amount of time it is apparent there is a problem with the knees as i am in constant pain.My dr keeps telling me "x-rays look fine" i had a 2nd opinion, dr tell me "x-rays look fine but knee seems a little loose." the knee used for my replacement is a zimmer nexgen complete knee solution, legacy knee, posterior stabilized, lps flex femoral component.Porous size g right.Trabecular metal tibial tray, fixed hearing, size 6.Prolong highly crosslinked polyethylene, 10mm 35 mm patella, trabecular metal.I know this was implanted after the 2/15 recall of zimmer nexgen, however, i am experiencing the same difficulties and problems of those people who receive an implant prior to 2/15.Zimmer has apparently not fixed the problem with their knee implant.On (b)(6) 2016, my implant knee locked up during physical therapy and the therapist had to stop therapy and used heat and cold packs along with massage to finally get it mobile again.Four days later, the same thing happened at home and i made a call to the on-call dr, as it was a sunday for an appointment the next day.I am 3 months away from losing my employment due to being unable to return to work as i cannot move around with efficiency and have constant pain as well as not being able to ascend and descend stairways normally and without pain.There is still 2 pockets of swelling on the front inside the outside of my kneecap after 9 months which dr says is "soft tissue swelling", i have difficulty in ascending / descending stairs as it creates pain, i have problems on uneven ground as the knee feels loose, i have pain ascending and descending slopes or grades, the knee pops, clicks and grinds and has the general feeling of being loose or unstable.I am unable to get a good nights rest as the knee becomes very stiff and painful if i turn over.I cannot sit in a restaurant booth for dinner as the knee becomes painful.I cannot sit in my computer chair longer than 15 mins.Without the knee becoming painful and stiff in a bent position.

• Brand Name: TRABECULAR METAL TIBIAL TRAY FIXED BEARING SIZE 6
• Type of Device: TIBIAL TRAY
• Manufacturer (Section D): ZIMMER INC.
• MDR Report Key: 5797886
• MDR Text Key: 49781972
• Report Number: MW5063421
• Device Sequence Number: 3
• Product Code: HSN
• 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: 07/12/2016
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 56 YR
• Patient Weight: 95