MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-309
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	09/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
Had a complete revision of a stryker knee implant within a 3 month period of initial implant.Revision included stryker products as well.Additional information reported in adverse consequences: during the 3 months following the initial implant, the need for the revision was diagnosed by the ortho surgeon.This was due to constant pain that extended from my knee to my calf.This was accompanied by persistent swelling, buckling, locking up and lateral movement.Additionally i broke my foot due to knee instability.Patient confirmed this pi is for the right knee.
Additional Manufacturer Narrative
The following devices were also listed in this report: tritanium patella-asymmetric; cat # 5552-l-299; lot # atkh.Tritanium bplate triathlon s3; cat # 5536b300; lot # ctd13898.Triathlon p/a cr beaded #3r; cat # 5517f302; lot # byr4t.Reported event: an event regarding instability involving a triathlon insert was reported.The event was not confirmed.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 medical records with a clinical consultant " these inquiries concern a patient who had a right total knee arthroplasty performed and within three months required revision of that knee.Five years later she required another revision of that knee.She also underwent a left total knee arthroplasty and within five months after that feels that she may need another revision because of pain swelling, etc.No pertinent clinical information is given.I have had no radiographs to review, lab results to review, imaging studies to review and no operation reports for clinical office notes to determine what the cause of her current problems are.The root cause of these events, for both the right knee and the left knee cannot be determined with certainty.In fact it is unclear exactly why this patient required revision so early on.The causes of postoperative pain, swelling, buckling, locking, etc.Are multifactorial including surgical factors with proper placement of the implants, proper positioning, proper restoration of kinematics and stability as well as proper achievement of fixation.The possibility of infection can also be considered.Other factors include the patient's compliance with postoperative protocols, activity level and bmi.It would be unlikely to have any causative issues with the implant itself.It is also unclear whether the patient had cemented or cementless implants.Cementless implants can cause symptoms if proper initial fixation is not achieved.There is no change in my conclusion of assessment based upon the additional information.As i said in my initial conclusion of assessment, "cementless implants can cause symptoms if proper initial fixation is not achieved.".-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the provided medical records were insufficient to confirm the event.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.
Event or Problem Description
Had a complete revision of a stryker knee implant within a 3 month period of initial implant.Revision included stryker products as well.Additional information reported in adverse consequences: during the 3 months following the initial implant, the need for the revision was diagnosed by the ortho surgeon.This was due to constant pain that extended from my knee to my calf.This was accompanied by persistent swelling, buckling, locking up and lateral movement.Additionally i broke my foot due to knee instability.Patient confirmed this pi is for the right knee.

• Brand Name: X3 TRIATHLON CS INSERT #3 9MM
• Common Device Name: 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-LIMERICK; raheen business park; limerick NJ NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15995375
• Report Number: 0002249697-2022-01841
• Device Sequence Number: 5950059
• Product Code: MBH
• UDI-Device Identifier: 07613327045727
• UDI-Public: 07613327045727
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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: 12/31/2019
• Device Model Number: 5531-G-309
• Device Catalogue Number: 5531G309
• Device Lot Number: LEB493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 54 KG