MAUDE Adverse Event Report: STRYKER STRYKER 1ST 2ND KNEE STRYKER TRI ATHLON

Device Problem Break (1069)

Patient Problems Pain (1994); Disability (2371)

Event Date 12/06/2011

Event Type  Injury  

Event Description

Stryker gave us these product inquiry no: 731316 and 731338 knee total replacement using stryker knee (b)(6) 2011.Knee came apart requiring another revision (b)(6) 2013 using a stryker knee.This totally caused me further disability causing me severe pain causing me to use a cane and strong medication drugs, morphine, 100 mg and 30mg er.I notified stryker on or about (b)(6) 2015 about the issues i have.They sent medical releases via (b)(6) on or about (b)(6) 2015.I promptly returned all info required (b)(6) 2015.After that i did a f/u call about 6 weeks later about (b)(6) 2015.I was told they received most of my records, but had only 2 more to get.I then called them on or about mid april was told all records were complete and turned over to a doctor review board for review that may take up to 3 weeks.In may, i again called this was 4 weeks later and told everything was complete, i would receive a letter from stryker concern their decision.For months, i talk and called at least 10 times with nothing but promise, lies, and blaming others for not calling my me or sending info.I called their head quarters in october same game, the run around, still no results, no report nothing, not even return call.Second was triathlon revised total knee 1st stryker unk.Stryker would not give info on first knee implant.I believe fda had recalls on stryker knee products still refuse to send their report on my knee almost 1 year now.

• Brand Name: STRYKER 1ST 2ND KNEE STRYKER TRI ATHLON
• Type of Device: STRYKER 1ST 2ND KNEE STRYKER TRI ATHLON
• Manufacturer (Section D): STRYKER
• MDR Report Key: 5319964
• MDR Text Key: 34249894
• Report Number: MW5058678
• Device Sequence Number: 1
• Product Code: HRY
• 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: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 59 YR
• Patient Weight: 54