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

Model Number 5532-G-411

Device Problems Unstable (1667); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Pain (1994); Injury (2348); Ambulation Difficulties (2544)

Event Date 10/18/2019

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.

Event Description

Information received in follow-up includes an operative report for a right knee revision on (b)(6) 2019.Noted in the records are the following: ".Fell in the bathtub.She had immediate pain.Continued to have pain and disability.Found to have a rupture patellar tendon.Failed right total knee arthroplasty with dislocation of the prosthesis.Instability of her prosthetic joint." a size 4 primary baseplate (implanted (b)(6) 2009) and a 4x11 ps insert (implanted (b)(6) 2018) were revised to a size 4 universal baseplate with stem and augments, and a 4x13 ts insert.

Manufacturer Narrative

Reported event: an event regarding disassociation, failed right total knee arthroplasty with dislocation of the prosthesis is reported involving triathlon insert.The event was confirmed based on medical review.Method & results: product evaluation and results- product inspection - not performed because device was not returned.Clinical review: a review of the provided medical records and/or x-rays by a clinical consultant stated that : a review of the provided medical records and/or x-rays by a clinical consultant stated that : the following adverse events were identified: left: failed patellar component with resection arthroplasty, revision left knee, periprosthetic infection, multiple aspirations and infection.Right: patellar component failure and revision, 2nd revision for knee dislocation and patellar tendon rupture.Conclusion of assessment: the mechanisms of failure and causes of revision in both knees appeared dynamic and unrelated to the implants.This was a very complicated case in a patient with multiple comorbid conditions.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the event was reported about revision due to disassociation, failed right total knee arthroplasty with dislocation of the prosthesis involving triathlon insert.The event was confirmed based on medical review.The exact cause of the event could not be determined because insufficient information was provided.Further information is needed to complete the investigation for determining its root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.

Event Description

Information received in follow-up includes an operative report for a right knee revision on (b)(6) 2019.Noted in the records are the following: ".Fell in the bathtub she had immediate pain continued to have pain and disability found to have a rupture patellar tendon.Failed right total knee arthroplasty with dislocation of the prosthesis instability of her prosthetic joint." a size 4 primary baseplate (implanted (b)(6) 2009) and a 4x11 ps insert (implanted (b)(6) 2018) were revised to a size 4 universal baseplate with stem and augments, and a 4x13 ts insert.

• 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
• MDR Report Key: 10206456
• MDR Text Key: 198137352
• Report Number: 0002249697-2020-01320
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050714
• UDI-Public: 07613327050714
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 5532-G-411
• Device Catalogue Number: 5532-G-411
• Device Lot Number: XR7T2W
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 117