MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5532-G-511

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/21/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was discarded and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

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.

Manufacturer Narrative

An event regarding trauma involving a triathlon insert was reported.Conclusion: review of the medical records by the clinician indicated: "a fall resulted in a traumatic patellar dislocation and increasing the poly insert by 2-millimeters resulted in clinical improvement." there are no failures or allegations against the triathlon insert.Based on the provided information, the product reported in this investigation did not contribute to the event.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.

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.M.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: TRIATHLON PS X3 TIBIAL INSERT
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5997238
• MDR Text Key: 56397088
• Report Number: 0002249697-2016-03155
• 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,Followup
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 5532-G-511
• Device Lot Number: MNE4Y4
• 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: 04/07/2014
• 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): Required Intervention
• Patient Age: 90 YR
• Patient Weight: 83