MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-511
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
Patient has instability in his right knee.Femur appears to be able to shift posteriorly.
Additional Manufacturer Narrative
Reported event: an event regarding instability involving a triathlon insert was reported.The event was confirmed by 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.Clinician review: a review of the provided medical information by a clinical consultant indicated: documents reviewed: 10/09/2020: stryker pi report undated x-ray: right lateral tka with posterior subluxation implants: triathlon x3 cs insert size #5 11mm confirmation: the abnormal posterior position of the femur on the tibia was confirmed root cause: the instability and posterior subluxation may be the result of a pcl rupture.The root cause cannot be ascertained without assessment of medical records and additional radiographic images.Review of the device history: records indicate (b)(4) devices were manufactured and accepted into final stock between 09 april 2013 and the 12 april 2013 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.H3 other text: device not returned.
Event or Problem Description
Patient has instability in his right knee.Femur appears to be able to shift posteriorly.

• Brand Name: X3 TRIATHLON CS INSERT #5 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10779624
• Report Number: 0002249697-2020-02313
• Device Sequence Number: 3657008
• Product Code: MBH
• UDI-Device Identifier: 07613327045864
• UDI-Public: 07613327045864
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 5531-G-511
• Device Catalogue Number: 5531G511
• Device Lot Number: LDG516
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR