MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G313
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was brought to or for revision tkr for subluxation of total knee components.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a triathlon insert was reported.The event was confirmed via clinician review of the provided medical records.Method & results: -device 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 records by a clinical consultant stated the following comments: "i can confirm that the patient had a primary cemented total knee arthroplasty presumably on the date supplied since i was able to see a lateral view of the implant in place with virtual dislocation.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of late subluxation/dislocation are multifactorial including surgical technique in the way that the implants are positioned, the integrity of the ligament complex especially in flexion when one is using cs component rather than at ps component.Having said that, this event was an anterior dislocation/subluxation and not posterior.Certainly, trauma and gradual stretching of the ligament complexes can contribute as well as the patient's lifestyle, activity level and bmi.In this case the patient's bmi is quite elevated.In this case, it is my opinion that the malposition of the tibial component in hyper flexion certainly can contribute to anterior subluxation/dislocation.I would not assign any causality to the implant or the insert.One would not expect satisfactory performance with the tibia in such hyper flexion." -device history review: not performed as the lot number is invalid.-complaint history review: not performed as the lot number is invalid.Conclusion: it was reported that the patient was revised due to subluxation/dislocation.A review of the provided medical records by a clinical consultant stated the following comments: "i can confirm that the patient had a primary cemented total knee arthroplasty presumably on the date supplied since i was able to see a lateral view of the implant in place with virtual dislocation.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of late subluxation/dislocation are multifactorial including surgical technique in the way that the implants are positioned, the integrity of the ligament complex especially in flexion when one is using cs component rather than at ps component.Having said that, this event was an anterior dislocation/subluxation and not posterior.Certainly, trauma and gradual stretching of the ligament complexes can contribute as well as the patient's lifestyle, activity level and bmi.In this case the patient's bmi is quite elevated.In this case, it is my opinion that the malposition of the tibial component in hyper flexion certainly can contribute to anterior subluxation/dislocation.I would not assign any causality to the implant or the insert.One would not expect satisfactory performance with the tibia in such hyper flexion." 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.

• Brand Name: X3 TRIATHLON CS INSERT #3 13MM
• 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 NA ; EI NA
• Manufacturer Contact: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19700162
• Report Number: 0002249697-2024-00974
• Device Sequence Number: 17036318
• Product Code: MBH
• UDI-Device Identifier: 07613327045741
• UDI-Public: 07613327045741
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2024

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 Catalogue Number: 5531G313
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 114 KG