MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE5 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531-G-513-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right knee was revised due to suspected infection.An i&d and washout was performed, and a 5x13 cs insert was revised to a 5x11 cs insert.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
The following devices were also listed in this report: tri cemented stem 12mmx50mm; cat# 5560-s-112 ; lot# 1172590k triathlon cr fem comp #5 r-cem; cat# 5510f502 ; lot# atadu tri ts baseplate size 5; cat# 5521-b-500 ; lot# oro9ya triathlon asymmetric x3 patella; cat# 5551-g-350-e ; lot# 4j9w.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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, functional and dimensional inspections could not be 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 the patient was revised due to infection.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.Further information such as pathology reports, pre- and post-operative x-rays and the revision 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.

• Brand Name: X3 TRIATHLON CS INS SIZE5 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 20195665
• Report Number: 0002249697-2024-01258
• Device Sequence Number: 20501880
• Product Code: MBH
• UDI-Device Identifier: 07613327336719
• UDI-Public: 07613327336719
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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 Expiration Date: 01/17/2025
• Device Catalogue Number: 5531-G-513-E
• Device Lot Number: LJT400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2020
• 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: 63 YR
• Patient Sex: Male