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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPEDICS/STRYKER CORP / HOWMEDICA COMPUTER ASSISTED NAVIGATION SOFTWARE Back to Search Results
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).
 
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Brand NameCOMPUTER ASSISTED NAVIGATION SOFTWARE
Type of DeviceCOMPUTER ASSISTED NAVIGATION SOFTWARE
Manufacturer (Section D)
STRYKER ORTHOPEDICS/STRYKER CORP / HOWMEDICA
MDR Report Key6541182
MDR Text Key74475639
Report NumberMW5069532
Device Sequence Number4
Product Code OLO
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received05/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberLCE977
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/01/2017 Patient Sequence Number: 1
Treatment
HIGH BLOOD PRESSURE MEDS
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