MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 2. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-209-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: tri cemented stem 12mmx100mm; cat# 5560-s-212; lot# 1129995k.Simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# mkd084.Simplex p full dose 1 pack; cat# 6191-1-001; lot# rhd088 x 2.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.H3 other text : device not returned.
Event or Problem Description
The following was reported: i&d of an infected triathlon ts left knee with poly swap.
Additional Manufacturer Narrative
The following devices were also listed in this report: tri cemented stem 12mmx100mm; cat# 5560-s-212; lot# 1129995k.Simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# mkd084.Simplex p full dose 1 pack; cat# 6191-1-001; lot# rhd088 x 2.Triath fem distal aug 5mm - size 1 left; cat# 5540-a-101; lot# hg37r.Triath fem distal aug 10mm - size 1 left; cat# 5541-a-101; lot# geu3e.Tri post augment sz1 5mm; cat# 5543-a-100; lot# hxz4t x 2.Tri ts femur sz1 left; cat# 5512-f-101; lot# heo4h.Tri lm/rl tib aug sz2 5mm; cat# 5545-a-201; lot# xl75172d.Tri rm/ll tib aug sz2 5mm; cat# 5545-a-202; lot# erhcl9d.Tri ts baseplate size 2; cat# 5521-b-200; lot# lbh9xa.Tri cemented stem 12mmx100mm; cat# 5560-s-212; lot# 1129995k.Simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# mkd084.Simplex p full dose 1 pack; cat# 6191-1-001; lot# rkd131 x 2.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.Also relate to infection.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 return of the device, 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
The following was reported: i&d of an infected triathlon ts left knee with poly swap.

• Brand Name: NO 2. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 17770464
• Report Number: 0002249697-2023-01053
• Device Sequence Number: 15222213
• Product Code: MBH
• UDI-Device Identifier: 07613327287837
• UDI-Public: 07613327287837
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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: 07/31/2026
• Device Catalogue Number: 5537-G-209-E
• Device Lot Number: NM50TT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female