MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #2; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5520B200

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problem Pain (1994)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

An event regarding mal-alignment involving a triathlon baseplate was reported.The event was confirmed.Method and results: device evaluation and results: devices were not returned for evaluation.Medical records received and evaluation: review of the medical records and x-rays provided concluded "left total knee arthroplasty with a marked varus position of the tibial component at approximately 10° to 15° of varus.There is no evidence of loosening of the three components of the total knee arthroplasty and the patellar tracking appears nominal." this conclusion suggests malposition of the components at the primary surgery.The ¿burning pain in the tibia¿ described in the event description suggests reflex sympathetic dystrophy.There is no evidence that factors of faulty prosthetic design, manufacturing, or materials are responsible for this clinical situation." device history review: records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: clinician review of the medical records and x-rays provided suggests malposition of the tibial baseplate component.No further investigation for this event is possible at this time.If devices and / or additional information become available, this investigation will be reopened.Not returned.

Event Description

It was reported that the patient did not have any pain until last year.Now the patient is reporting that she feels a burning in the tibia under the knee.The patient also states that her knee is at an odd slant.She is reporting that she will be under going revision surgery but no date is set.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #2
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6209754
• MDR Text Key: 63407173
• Report Number: 0002249697-2016-04024
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2013
• Device Catalogue Number: 5520B200
• Device Lot Number: SFYFR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 91