MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT PSR NUM3 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	8532-G-309-E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/06/2024
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.
Event or Problem Description
Primary tka surgery was performed on (b)(6) 2024.Tka insert was dislocated on (b)(6) 2024.Revision surgery was performed on (b)(6) 2024.
Event or Problem Description
Primary tka surgery was performed on (b)(6) 2024.Tka insert was dislocated on (b)(6) 2024.Revision surgery was performed on (b)(6) 2024.
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: conclusion/assessment: revision surgery performed for mal seating and subsequent dislocation of a polyethylene bearing.Event confirmation: the event, mal seating/dislocation of a polyethylene component can be confirmed.The revision surgery cannot be confirmed.Root cause: the root cause for the polyethylene dislocation would be mal seating.The root cause of the unconfirmed revision would be dislocation of the polyethylene.Device 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.Conclusion: a review of the provided medical records by a clinical consultant stated the following comments: conclusion/assessment: revision surgery performed for mal seating and subsequent dislocation of a polyethylene bearing.Event confirmation: the event, mal seating/dislocation of a polyethylene component can be confirmed.The revision surgery cannot be confirmed.Root cause: the root cause for the polyethylene dislocation would be mal seating.The root cause of the unconfirmed revision would be dislocation of the polyethylene.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 INSERT PSR NUM3 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19839254
• Report Number: 0002249697-2024-01034
• Device Sequence Number: 17867474
• Product Code: JWH
• UDI-Device Identifier: 07613327481303
• UDI-Public: 07613327481303
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: 8532-G-309-E
• Device Lot Number: W81N77
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/06/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Race: Asian