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

Model 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	05/12/2023
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.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 the devices were anufactured 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 return of the device, pathology reports, pre- and post-operative x-rays and the primary 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.Device not returned.
Event or Problem Description
Dr.Performed an i&d with tibial insert exchange of a left knee triathlon ts due to infection.
Additional Manufacturer Narrative
The following devices were also listed in this report: 5560-s-212 tri cemented stem 12mmx100mm 1129995k 6197-9-001 simplex p with tobramycin 1 pack mkd084 6191-1-001 simplex p full dose 1 pack rhd088 (x2) 5540-a-101 triath fem distal aug 5mm - size 1 left hg37r 5541-a-101 triath fem distal aug 10mm - size 1 left geu3e 5543-a-100 tri post augment sz1 5mm hxz4t (x2) 5512-f-101 tri ts femur sz1 left heo4h 5545-a-201 tri lm/rl tib aug sz2 5mm xl75172d 5545-a-202 tri rm/ll tib aug sz2 5mm erhcl9d 5521-b-200 tri ts baseplate size 2 lbh9xa 5560-s-212 tri cemented stem 12mmx100mm 1129995k 6197-9-001 simplex p with tobramycin 1 pack mkd084 6191-1-001 simplex p full dose 1 pack rkd131 (x2) it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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 return of the device, pathology reports, pre- and post-operative x-rays and the primary 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
Dr.Performed an i&d with tibial insert exchange of a left knee triathlon ts due to infection.

• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17037529
• Report Number: 0002249697-2023-00610
• Device Sequence Number: 12504009
• 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 Model Number: 5537-G-209-E
• Device Catalogue Number: 5537-G-209-E
• Device Lot Number: 6R1LYP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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: 70 YR
• Patient Sex: Female