MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT NO 3 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531-G-309-E
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported "my knee never fully worked after the surgery and the implant became loose , my knee would bend all the way backwards , i¿ve fallen a few times and so much pain.I also have to get knee replacement to replace the implant and currently wearing a brace.Did therapy at home and with therapist.Scheduled surgery in march to replace the original implant.".
Additional Manufacturer Narrative
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.
Event or Problem Description
The following was reported "my knee never fully worked after the surgery and the implant became loose , my knee would bend all the way backwards , i¿ve fallen a few times and so much pain.I also have to get knee replacement to replace the implant and currently wearing a brace.Did therapy at home and with therapist.Scheduled surgery in march to replace the original implant.".
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon cr fem comp #3 l-cem; cat# 5510f301 ; lot# pna3r.Tri ts baseplate size 3; cat# 5521-b-300 ; lot# idl9yb.Simplex hv with gentamicin us 1 pack; cat # 6195-1-001; lot# 145bb909gc.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 instability 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: a review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: no radiographs or preoperative or postoperative medical records were provided for review.Very little information was provided for review outside of the patient complaint and an operative report.The patient appears to have undergone a mako total knee arthroplasty with triathlon cemented knee components.Again, no postoperative records were provided but the patient complains of knee instability and requirement for revision arthroplasty.Event confirmation: the events cannot be confirmed without additional medical information.Root cause: a root cause cannot be ascertained as there is a paucity of medical records to support the complaints and the complaints cannot be confirmed." 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.Conclusions: it was reported that the patient is experiencing pain due to loosening of triathlon components.A review of the provided medical records by a clinical consultant indicated: "no radiographs or preoperative or postoperative medical records were provided for review.Very little information was provided for review outside of the patient complaint and an operative report.The patient appears to have undergone a mako total knee arthroplasty with triathlon cemented knee components.Again, no postoperative records were provided but the patient complains of knee instability and requirement for revision arthroplasty." 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 INSERT NO 3 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: 18812915
• Report Number: 0002249697-2024-00318
• Device Sequence Number: 8170044
• Product Code: MBH
• UDI-Device Identifier: 07613327336955
• UDI-Public: 07613327336955
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: 09/30/2026
• Device Catalogue Number: 5531-G-309-E
• Device Lot Number: 11888R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• 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: Required Intervention; Hospitalization; Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 91 KG