MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM PATELLA-ASYMMETRIC; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number 5552-L-320

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Injury (2348); Joint Dislocation (2374)

Event Date 12/21/2015

Event Type  Injury  

Manufacturer Narrative

An event regarding trauma involving a triathlon patella was reported.The event was confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: the provided medical records were reviewed by a consulting clinician who indicated: "in this elderly patient living in an extended care facility and dependent upon a walker, a fall resulted in a traumatic patellar dislocation.The extensor mechanism ruptured in her left total knee.Soft tissue repair of the extensor mechanism and increasing the poly insert by 2-millimeters resulted in clinical improvement.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation." device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: review of the medical records by the clinician indicated a fall resulted in a traumatic patellar dislocation.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation.No further investigation for this event is possible.If devices and/or additional information become available, this investigation will be reopened.Remains implanted.

Event Description

On (b)(6) 2015 the patient had a fall in the bathroom.The left knee twisted underneath her causing her patella to dislocate laterally.She went to the hospital and was given an appointment to follow up with dr.(b)(6).She lives in the masonic home and has typically been ambulating with a walker.She is in a wheelchair now in the office.She states that the patella does not cause her a lot of pain right now, but has been chronically dislocated since the fall.Dr.(b)(6) saw patient in the office on (b)(6) 2016 and scheduled her for repair of left knee extensor mechanism with possible left total knee revision depending on if the position of the implants are in proper alignment.On (b)(6) 2016 patient underwent revision left tka with liner exchange and reconstruction of extensor mechanism rupture with a lateral release and medial imbrication.

• Brand Name: TRITANIUM PATELLA-ASYMMETRIC
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6213986
• MDR Text Key: 63564325
• Report Number: 0002249697-2016-04074
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2019
• Device Catalogue Number: 5552-L-320
• Device Lot Number: A0KRR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2014
• 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; Required Intervention
• Patient Age: 90 YR
• Patient Weight: 83