MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 3 TRIATH TS PLUS TIB INS X3 POLY 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER

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	11/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon ctr femconeaug sz3&4r; cat# 5549-a-642; lot# km4a triath fem distal aug 5mm - size 3 right; cat# 5540-a-302; lot# ;b749l triath fem distal aug 5mm - size 3 right; cat# 5540-a-302; lot# aul3l tri ts femur sz3 right; cat#5512-f-302 ; lot# dgz7h tri cemented stem 12mmx50mm; cat# 5560-s-112; lot# 0100474m tri cemented stem 12mmx50mm; cat# 5521-b-300; lot# duo3ea triathlon sym cone aug sz a; cat# 5549-a-110; lot# ejm4 tri rm/ll tib aug sz3 5mm; cat# 5545-a-302; lot# erfwn2d tri lm/rl tib aug sz3 5mm; cat# 5545-a-301; lot# erffp6d tri cemented stem 12mmx50mm; cat# 5560-s-112; lot# 0086190m simplex hv with gentamicin us 1 pack; cat # 6195-1-001; lot #926ba906aa simplex hv with gentamicin us 1 pack; cat # 6195-1-001; lot #926ba906aa 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 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.
Event or Problem Description
As reported: "patient revised due to infection.All implants were removed in a spacer was implanted.No other information available due to hospital policy." right knee.

• Brand Name: NO 3 TRIATH TS PLUS TIB INS X3 POLY 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER
• 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 20805420
• Report Number: 0002249697-2024-01653
• Device Sequence Number: 9940839
• Product Code: JWH
• UDI-Device Identifier: 07613327287974
• UDI-Public: 07613327287974
• Combination Product (Y/N): N
• 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): 11/28/2024

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: 5537-G-313-E
• Device Lot Number: 6W3YVH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 11/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2022
• 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: 51 YR
• Patient Sex: Female