MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5537-G-309

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.The following devices were also listed in this report: triathlon asymmetric x3 patella; cat# 5551-g-320; lot# ymay.Triathlon ps fem component, cemented; cat# 5515-f-301; lot# nfrwa.Tri ts baseplate size 3; cat# 5521-b-300; lot# tvwhb.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.

Event Description

It was reported through the communication of an attorney that allegedly the patient was revised due to failed left total knee arthroplasty.

Manufacturer Narrative

An event regarding incorrect selection involving a triathlon patella was reported.The event was confirmed via medical review.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: multiple procedure-related factors including poor femoral cementation technique with malalignment of the knee in excessive valgus further contributing to an overload condition and the pain magnified by patellofemoral overstuffing have in concert contributed to immediate fixation failure of the triathlon ps/ts femoral component within the first few weeks post primary surgery on (b)(6) 2016, causing severe and persistent pain with functional limitations and secondary instability ultimately requiring revision surgery with exchange of all triathlon devices to depuy revision knee devices on (b)(6) 2018.No device-related factors are associated with any of the implanted devices at any time.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the medical review revealed that the patella was found too thick with 28-mm, which was determined to be a procedural related factor which contributed to immediate fixation failure of the triathlon ps/ts femoral component.No device-related factors are associated with any of the implanted devices at any time.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported through the communication of an attorney that allegedly the patient was revised due to failed left total knee arthroplasty.Update on 26-nov-2019 by qs based on medical review: left knee revision surgery was performed on (b)(6) 2018, under the diagnosis of ¿failed left knee arthroplasty¿ with exchange of all stryker components for depuy (non stryker) revision knee devices.At exploration, the instability was confirmed and the patella was found too thick with 28-mm.The femoral component was deemed loose as it could be ¿popped out¿ without effort.Only 7-weeks post surgery, the second x-rays of (b)(6) 2016, confirmed already significant proximal migration of the femoral component with more than 1-cm subsidence compared with the previous x-ray of (b)(6) 2016, with lucency and bone resorption along almost the entire femoral implant-bone interface.

• Brand Name: NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8878689
• MDR Text Key: 153818321
• Report Number: 0002249697-2019-02779
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327027129
• UDI-Public: 07613327027129
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 5537-G-309
• Device Lot Number: MLP80H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR