MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5515-F-501

Device Problem Loss of Osseointegration (2408)

Patient Problems Unspecified Infection (1930); Inadequate Osseointegration (2646)

Event Date 05/25/2023

Event Type  Injury  

Event Description

It was reported that the patient's left knee was revised.As reported: "the revision today was secondary to infection and femoral loosening." a ps femoral component and ts insert were revised to a ts femoral component with stem and augments and another ts insert.The stemmed tibial baseplate remained in situ.

Manufacturer Narrative

Reported event: an event regarding loosening and infection involving a triathlon femoral component 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 referenced.There has been 1 other similar event for the reported sterile lot.A review of both the sterilization data and microbiology data was performed for this sterile lot commonality.It was identified that the sterilization data was within specification and no microbiology excursions were noted for this lot and as such no further review is required.Conclusions: it was reported that the patient was revised due to loosening of the femoral component and infection.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 revision 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.The following devices were also listed in this report: device name#no 5.Triathlon ts plus tibial insert x3 poly 19mm ; cat#5537-g-519 ; lot#1m010d; device name#tri ts baseplate size 5 ; cat#5521-b-500 ; lot#nafl; device name#tri cemented stem 12mmx50mm ; cat#5560-s-112 ; lot#0035626e.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: TRIATHLON PS FEM COMPONENT CEMENTED
• Type of Device: 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17149892
• MDR Text Key: 317462528
• Report Number: 0002249697-2023-00686
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050394
• UDI-Public: 07613327050394
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042993
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/19/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 5515-F-501
• Device Catalogue Number: 5515-F-501
• Device Lot Number: KJMPD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female