MAUDE Adverse Event Report: STRYKER STRYKER ORTHO FULL DOSE USA; SIMPLEX P-BONE CEMENT

Catalog Number 6191-1-001

Device Problems Nonstandard Device (1420); Device Slipped (1584)

Patient Problems Pain (1994); Swelling (2091); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/09/2012

Event Type  Other  

Event Description

I had both knees replace in 2012 with smith&nephew knees.Now i need revisions, but i can't have them done, one is to loose and one is too tight with no room to bend.I'm in pain 24/7 there is swelling, popping and pain.I was told that the oxinium genesis ii knees were recalled from 2003/2010.Sending copies of complete identification of both knees.I can't sit in a bath tub, because my knees won't bend enough for me to get out.I can only walk about 3 blocks.Then i have to rest to be able to walk back.After this my knees are so swollen and i'm in so much pain i have rest for awhile until i can stand again.Every morning my knees are so stiff i can hardly move.New dr.(b)(6).Need revisions.

• Brand Name: STRYKER ORTHO FULL DOSE USA
• Type of Device: SIMPLEX P-BONE CEMENT
• Manufacturer (Section D): STRYKER
• MDR Report Key: 5702717
• MDR Text Key: 46900834
• Report Number: MW5062679
• Device Sequence Number: 5
• Product Code: LOD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• 11 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6191-1-001
• Device Lot Number: RKS163
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 77