MAUDE Adverse Event Report: STRYKER ORTHOPEDICS/STRYKER CORP / HOWMEDICA COMPUTER ASSISTED NAVIGATION SOFTWARE

Lot Number LCE977

Device Problems Defective Component (2292); Failure to Align (2522)

Patient Problem No Code Available (3191)

Event Date 07/23/2012

Event Type  Injury  

Event Description

I had to have a total knee replacement in (b)(6) 2012.It was never right.I had to have revision surgery.On (b)(6) in 2017, my orthopedic surgeon had to take out the entire original knee implant and replace it with a new one.The original implant was a total failure.The femoral component was wrong size.Femoral component was rotated totally wrong.The patella component was wrong size.The tibial component was totally misaligned.Problem was with the implant.The stryker rep who operated the navigation software.The computer assisted navigation software was defective.The stryker triathlon implant was defective.The whole thing was a mess.Which my orthopedic surgeon who did the revision surgery spells out in his operative report.His name is dr.(b)(6).

• Brand Name: COMPUTER ASSISTED NAVIGATION SOFTWARE
• Type of Device: COMPUTER ASSISTED NAVIGATION SOFTWARE
• Manufacturer (Section D): STRYKER ORTHOPEDICS/STRYKER CORP / HOWMEDICA
• MDR Report Key: 6541182
• MDR Text Key: 74475639
• Report Number: MW5069532
• Device Sequence Number: 4
• Product Code: OLO
• 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: 05/01/2017
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: LCE977
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: HIGH BLOOD PRESSURE MEDS
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 61 YR
• Patient Weight: 67