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-809
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event.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.Should additional information become available it will be reported in a supplemental report.The following devices were also listed in this report: catalog 6191-1-001, simplex p full dose 1 pack, lot rea068.Catalog 5515f802,triathlon ps fem comp #8r-cem, lot aem4f.Catalog 5521-b-800,tri ts baseplate size 8, lot d4l3oa.Catalog 5551-g-401,triathlon asymmetric x3 patella, lot x685.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: "right knee poly exchange due to superficial infection.Case done on (b)(6) 2020.No more information is available per doctor." rep provided the primary usage sheet and indicated that the insert was revised.

• 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: 9822892
• Report Number: 0002249697-2020-00509
• Device Sequence Number: 1538355
• Product Code: MBH
• UDI-Device Identifier: 07613327046342
• UDI-Public: 07613327046342
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• 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): 03/12/2020

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: 01/31/2022
• Device Model Number: 5532-G-809
• Device Catalogue Number: 5532-G-809
• Device Lot Number: 2W857D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/12/2020
• 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: 138