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

Model Number	5532-G-809-E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	02/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: no other similar events were reported for the lot or sterile lot referenced.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including pathology reports, operative reports, progress notes, x- rays and return of the device are needed to fully investigate the event.Infection is a known possible adverse outcome of surgery, as noted in the instructions for use.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.When the sterile barrier of any device is opened, the sterility of that device becomes a function of handling and surgical technique and is beyond stryker¿s control.Infection due to bacterial contamination, as supplied from the manufacturer, is an extremely rare event (see technical report 0000128012).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: triathlon ps fem comp #8r-cem; cat# 5515f802; lot# aem4f, tri ts baseplate size 8; cat# 5521-b-800; lot# d4l3oa, triathlon asymmetric x3 patella; cat# 5551-g-401; lot# x685, simplex p - us full dose 10-pk; cat# 61911010; lot# rea068, simplex p - us full dose 10-pk; cat# 61911010; lot# rea068.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
As reported: "patient's right knee was revised due to infection.This is the second revision of the patient's right knee.Revision 1 was a poly swap.All information the hospital has on the patient is attached to this email." rep provided primary and revision usage sheets.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9884115
• Report Number: 0002249697-2020-00605
• Device Sequence Number: 2897251
• Product Code: MBH
• UDI-Device Identifier: 07613327337648
• UDI-Public: 07613327337648
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

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: 01/31/2024
• Device Model Number: 5532-G-809-E
• Device Catalogue Number: 5532-G-809-E
• Device Lot Number: 8248PD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/26/2020
• 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: 81 YR
• Patient Weight: 148