MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 3 TRIATH TS PLUS TIB INS X3 POLY 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-313-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "patient was revised due to possible infection.No other information available due to hospital policy." right knee.A 3x13 ts insert was exchanged for another.
Additional Manufacturer Narrative
The following device was also listed in this report: device; triathlonctrfemconeaug sz3&4r ; cat# 5549-a-642 ; lot# km4a.Device; triath fem distal aug 5mm - size 3 right ; cat# 5540-a-302 ; lot# b749l.Device; triath fem distal aug 5mm - size 3 right ; cat# 5540-a-302 ; lot# aul3l.Device; tri ts femur sz3 right ; cat# 5512-f-302 ; lot# dgz7h.Device; tri cemented stem 12mmx50mm ; cat# 5560-s-112 ; lot# 0100474m.Device; tri ts baseplate size 3 ; cat# 5521-b-300 ; lot# duo3ea.Device; triathlon sym cone aug sz a ; cat# 5549-a-110 ; lot# ejm4.Device; tri rm/ll tib aug sz3 5mm ; cat# 5545-a-302 ; lot# erfwn2d.Device; tri lm/rl tib aug sz3 5mm ; cat# 5545-a-301 ; lot# erffp6d.Device; tri cemented stem 12mmx50mm ; cat# 5560-s-112 ; lot# 0086190m.Device; simplex hv with gentamicin us 1 pack ; cat# 6195-1-001 ; lot# 926ba906aa.Device; simplex hv with gentamicin us 1 pack ; cat# 6195-1-001 ; lot# 926ba906aa.Device; simplex hv with gentamicin us 1 pack ; cat# 6195-1-001 ; lot# 926ba906aa.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 referenced.There have been 2 other similar events for the sterile lot referenced.A review of both the sterilization data and microbiology data was performed for this sterile lot commonality.It was identified that the sterilization data was within specification and no microbiology excursions were noted for this lot and as such no further review is required.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: NO 3 TRIATH TS PLUS TIB INS X3 POLY 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19508541
• Report Number: 0002249697-2024-00864
• Device Sequence Number: 20688845
• Product Code: MBH
• UDI-Device Identifier: 07613327287974
• UDI-Public: 07613327287974
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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: 08/21/2024
• Device Catalogue Number: 5537-G-313-E
• Device Lot Number: WL0DLX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 50 YR
• Patient Sex: Female