MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-709
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Infection of right tka.Patient was admitted for exploration, washout and polyethylene insert exchange.
Additional Manufacturer Narrative
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.Device not returned.
Event or Problem Description
Infection of right tka.Patient was admitted for exploration, washout and polyethylene insert exchange.
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon asymmetric x3 patella; cat# 5551-g-381-e; lot# k3al triathlon prim cem fxd bplt #7; cat# 5520b700; lot# lpy7n.Triathlon cr fem comp #7 r-cem; cat# 5510f702; lot# jen4e.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 confirmed via review of the provided medical records by a clinical consultant.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 information by a clinical consultant indicated: "this inquiry concerns an obese patient who underwent a primary robotically assisted right total knee arthroplasty.He subsequently developed a postoperative infection which required surgical treatment with debridement and polyethylene exchange approximately 10 months after the index surgery.I can confirm that these events occurred since i was able to examine the operation notes.The root cause cannot be determined with certainty.The causes of infection after total knee arthroplasty are multifactorial including surgical technique factors and patient factors.Contamination of the wound at the time of initial surgery can contribute but development of infection at 9 to 10 months following surgery most likely occurs because of seeding of the knee joint from a remote site.I would not assign any causality to the implants." -product history review: review of the device history records indicate the 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 the 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.A review of the provided medical information by a clinical consultant indicated: "this inquiry concerns an obese patient who underwent a primary robotically assisted right total knee arthroplasty.He subsequently developed a postoperative infection which required surgical treatment with debridement and polyethylene exchange approximately 10 months after the index surgery.I can confirm that these events occurred since i was able to examine the operation notes.The root cause cannot be determined with certainty.The causes of infection after total knee arthroplasty are multifactorial including surgical technique factors and patient factors.Contamination of the wound at the time of initial surgery can contribute but development of infection at 9 to 10 months following surgery most likely occurs because of seeding of the knee joint from a remote site.I would not assign any causality to the implants." the exact cause of the event could not be determined from the information provided.Further information such as pathology reports and 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: X3 TRIATHLON CS INSERT #7 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-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14338498
• Report Number: 0002249697-2022-00660
• Device Sequence Number: 6200356
• Product Code: MBH
• UDI-Device Identifier: 07613327046007
• UDI-Public: 07613327046007
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2022

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: 11/30/2025
• Device Model Number: 5531-G-709
• Device Catalogue Number: 5531G709
• Device Lot Number: LKJ300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 154 KG