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 Problem Insufficient Information (3190)

Patient Problems Aspiration/Inhalation (1725); Inflammation (1932); Pain (1994); Ambulation Difficulties (2544)

Event Date 02/14/2013

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 a report of left knee effusion after a recent fall.On (b)(6) 2013: "under sterile technique, her left knee was aspirated for blood-tinged fluid.".

Manufacturer Narrative

Reported event: an event regarding patient factors is reported involving triathlon insert.The event was confirmed based on medical review, but no device specific failure modes were identified or confirmed as aspiration can occur post-operatively for a number of reasons.Method & results: product evaluation and results- product inspection - material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.Clinical review: 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 patella 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 patella 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 patient factors is reported involving triathlon insert.The event was confirmed based on medical review, but no device specific failure modes were identified or confirmed as aspiration can occur post-operatively for a number of reasons.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.

Event Description

Information received in a report of left knee effusion after a recent fall.On (b)(6) 2013: "under sterile technique, her left knee was aspirated for blood-tinged fluid.".

• 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: 10152086
• MDR Text Key: 195088439
• Report Number: 0002249697-2020-01171
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 5532-G-411
• Device Catalogue Number: 5532-G-411
• Device Lot Number: MLJ6RJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR