MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-309
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.The following devices were also listed in this report: 5536b300tritanium bplate triathlon s3ctd3811, 5517f301triathlon p/a cr beaded #3lej9dm, 5552-l-350tritanium patella-asymmetrica23r.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient developed symptoms of acute infection and aspiration of synovial fluid from the right knee joint and inflammatory markers were indicative of deep infection.The patient underwent irrigation and debridement as well as revision of the polyethylene tibial insert on (b)(6) 2019.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a triathlon insert was reported.The event was confirmed through clinician review of the provided medical records.Method & results: device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: the patient had an infection in a total knee that had been placed approximately 5 years prior.The knee was treated as if the infection was acute and the patient underwent irrigation and debridement procedure with polyethylene exchange.Few clinical data were provided for the time period before or after the procedure.But there was no indication that the knee was not well functioning prior to the infection.This incident is unrelated to the implants that have been in place for 5 years.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusions: a review of the provided medical records and x-rays by a clinical consultant indicated: the patient had an infection in a total knee that had been placed approximately 5 years prior.The knee was treated as if the infection was acute and the patient underwent irrigation and debridement procedure with polyethylene exchange.Few clinical data were provided for the time period before or after the procedure.But there was no indication that the knee was not well functioning prior to the infection.This incident is unrelated to the implants that have been in place for 5 years.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
Patient developed symptoms of acute infection and aspiration of synovial fluid from the right knee joint and inflammatory markers were indicative of deep infection.The patient underwent irrigation and debridement as well as revision of the polyethylene tibial insert on (b)(6) 2019.

• Brand Name: X3 TRIATHLON CS INSERT #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
• MDR Report Key: 10725261
• Report Number: 0002249697-2020-02221
• Device Sequence Number: 11182343
• Product Code: MBH
• UDI-Device Identifier: 07613327045727
• UDI-Public: 07613327045727
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

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: 11/30/2019
• Device Model Number: 5531-G-309
• Device Catalogue Number: 5531G309
• Device Lot Number: LEA800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 72