MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5530-G-409-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.The following devices were also listed in this report: triathlon cr fem comp #4 r-cem; cat# 5510f402; lot# 77uxu; triathlon prim tib bplate cemented sz 4; cat# 5520-b-400; lot# s332n.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Orthopaedic registrar notified stryker employee about planned 1 stage revision (dair) procedure for infection.Surgical plan, exchange tibial bearing.Nil concerns from surgeon re.Implant, surgeon unwilling to share any further details (op reports, pathology, etc.) due to confidentiality and nil concerns over implant performance.Pus was found in the patient's knee.Debridement and washout was performed and a new implant implanted.The procedure was completed successfully with no delays.
Event or Problem Description
Orthopaedic registrar notified stryker employee about planned 1 stage revision (dair) procedure for infection.Surgical plan, exchange tibial bearing.Nil concerns from surgeon re.Implant, surgeon unwilling to share any further details (op reports, pathology, etc.) due to confidentiality and nil concerns over implant performance.Pus was found in the patient's knee.Debridement and washout was performed and a new implant implanted.The procedure was completed successfully with no delays.Additional information received: tibial base plate removed and all poly tibia implanted.This revision was due to infection only - not implant failure.Completed successfully.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, dimensional and functional inspection were not performed as the device was not returned.-clinician review: - no medical records were received for review with a clinical consultant.-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 or sterile lot referenced.Conclusions: it was reported that 'orthopaedic registrar notified stryker employee about planned 1 stage revision (dair) procedure for infection.Surgical plan, exchange tibial bearing.Nil concerns from surgeon re.Implant, surgeon unwilling to share any further details (op reports, pathology, etc.) due to confidentiality and nil concerns over implant performance.Implant details: triathlon size 4 rt.Femur, ref (b)(4), lot: 77uxu.Triathlon size 4 primary tibial baseplate, ref: (b)(4), lot: s332n.Triathlon tibial bearing size 4, 9mm cr, ref: (b)(4), lot: wt3nkk.Pus was found in the patient's knee.Debridement and washout was performed and a new implant implanted.The procedure was completed successfully with no delays.Removed implant ref: (b)(4), lot: wt3nkk.' all stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Additional information including pathology reports, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20979587
• Report Number: 0002249697-2024-01772
• Device Sequence Number: 3954982
• Product Code: MBH
• UDI-Device Identifier: 07613327382860
• UDI-Public: 07613327382860
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: 02/28/2026
• Device Catalogue Number: 5530-G-409-E
• Device Lot Number: WT3NKK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2021
• 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 Age: 79 YR
• Patient Sex: Female
• Patient Weight: 115 KG