MAUDE Adverse Event Report: STRYKER SHAPEMATCHCUTTINGGUIDE

Device Problem Insufficient Information (3190)

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

Event Date 01/01/2014

Event Type  malfunction  

Event Description

Had my knees replaced (right one on (b)(6) 2011 and second one, on (b)(6) 2011) using stryker shape match cutting guide.Now, almost 2 years later, having severe pain in my left knee.Seeing my surgeon's assistant tomorrow to see what is going on ((b)(6) 2014).I cannot walk, bend my knee without pain.Went through all of this twice already, first time the right, with surgery, recovery and therapy and then the left.I am tired of pain.

• Brand Name: SHAPEMATCHCUTTINGGUIDE
• Type of Device: SHAPEMATCHCUTTINGGUIDE
• Manufacturer (Section D): STRYKER
• MDR Report Key: 3557771
• MDR Text Key: 4213311
• Report Number: MW5033716
• Device Sequence Number: 1
• Product Code: HWT
• 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: 01/01/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/02/2014
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 104