MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5532-G-311
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.The following devices were also listed in this report: triathlon p/a ps beaded #2l; cat# 5516f201; lot# ayr6a.Tritanium bplate triathlon s3; cat# 5536b300; lot# ctd12228.Tritanium patella-asymmetric; cat# 5552-l-320 ; lot# ay32.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Triathlon tritanium implanted at initial surgery.Infected tka led to i&d and poly liner exchange.
Event or Problem Description
Triathlon tritanium implanted at initial surgery.Infected tka led to i&d and poly liner exchange.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a triathlon insert was reported.The event was confirmed by clinician review.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/or x-rays by a clinical consultant indicated: "adverse event identified: infection in left tka.Hazards: none clearly related to implants.Conclusion of assessment: the patient had an infection in her left tka approximately 2 years post-operatively.The infectious organism was streptococcus sanguis.The was some suggestion that this may have been hematogenous after dental work.The infection was treated with an i and d procedure and iv antibiotics.At 14 months post-operative the patient appeared to be doing well and infection free." device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been 1 other similar events for the lot and sterile lot, relate to the same device/patient, therefore no further trending is required for this commonality.Conclusions: it was reported that the patient's knee was revised due to infection.The available medical records were provided to the consulting clinician for a review which concluded that the patient had an infection in her left tka approximately 2 years post-operatively.The infectious organism was streptococcus sanguis.The was some suggestion that this may have been hematogenous after dental work.The infection was treated with an i and d procedure and iv antibiotics.At 14 months post-operative the patient appeared to be doing well and infection free.A microbiological assessment was completed by declan normoyle, principal microbiologist, stryker ireland who indicated: due to the nature of the organisms isolated ¿ susceptible to various modes of sterilisation - and specifically the sterilisation methodology employed by stryker, it is not probable that streptococcus sanguis could have originated from the implants.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: TRIATHLON PS X3 TIBIAL INSERT
• 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: 10964780
• Report Number: 0002249697-2020-02602
• Device Sequence Number: 19904215
• Product Code: MBH
• UDI-Device Identifier: 07613327050639
• UDI-Public: 07613327050639
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 02/17/2021

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: 10/31/2020
• Device Model Number: 5532-G-311
• Device Catalogue Number: 5532-G-311
• Device Lot Number: Y47HHA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 02/17/2021
• 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 Weight: 76