MAUDE Adverse Event Report: STRYKER HOWMEDICA STRYKER TRIATHALON CR; KNEE REPLACEMENT

Catalog Number 5551-5-320

Device Problems Incorrect Measurement (1383); Device Slipped (1584); Unstable (1667); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Weakness (2145); Joint Swelling (2356); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 05/01/2012

Event Type  Injury  

Event Description

On (b)(6) 2007, i had a total knee replacement.The physician implanted a stryker triathlon.In late 2010, i started experiencing problems with stiffness, knee popping, pain, swelling, and knee locking.After several months of complaining, i was referred to an orthopedic surgeon in (b)(6) 2011.Upon exam and x-rays, on (b)(6) 2012, a bone scan revealed slight loosening on the medical plateau.Femoral component appear to be slightly oversized.On (b)(6) 2012, arthroscopic surgery was performed and scar tissue was removed.This did not eliminate my previous symptoms of stiffness, swelling, excessive pain and knee locking.Also, underwent physical therapy (numerous sessions).Finally, on (b)(6) 2012, knee revision surgery was performed.The medical stated loosening of femoral component and part failed.My physician states he cannot contribute this failure to the knee although it was part of the knee.The original surgeons report states he used the stryker computer assisted navigation software and that he did not use the guides but rather eyeballed the cuts.Included with the computer navigation system was a tibial resection guide and has a detailed accounting of where the guides were placed and the cuts made with the exact saw used.I found on the internet the instructions to conduct a knee replacement using the otis match shapematch cutting guides and this physician followed the exact same instructions using the tibial resection guides.The fact the 2nd physician states it was slightly oversized makes me think the cutting guides were off and gave the wrong measurements.There was a problem with this cutting guide and resection guides prior to stryker purchasing it from otis.The recall should have gone back further.But, the fact the fda is leaving it up to the physician on whether or not to report it, many have gone unreported for previous years prior to the recall dates starting in 2010.Many people do not know to go out and file a report because i did not.I feel i was harmed as a result of this faulty product.I am on a cane permanently because of my instability, pain, swelling, weakness, and stiffness.My range of motion goes up and down.I cannot sit for prolonged periods of time without experiencing extreme stiffness and pain.

• Brand Name: STRYKER TRIATHALON CR
• Type of Device: KNEE REPLACEMENT
• Manufacturer (Section D): STRYKER HOWMEDICA
• MDR Report Key: 4504116
• MDR Text Key: 17297571
• Report Number: MW5040651
• Device Sequence Number: 1
• Product Code: MBH
• 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: 02/04/2015
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2012
• Device Catalogue Number: 5551-5-320
• Device Lot Number: 601
• Other Device ID Number: TRIATHLON X3
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 57 YR
• Patient Weight: 104