MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G711
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: tritanium bplate triathlon s7; cat# 5536-b-700; lot# ctd8088, triathlon p/a cr beaded #7r; cat# 5517-f-702; lot# emdhc, tritanium patella-asymmetric; cat# 5552-l-381; lot# a48l.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicates the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the sterile lot referenced.Not available.
Event or Problem Description
Rep reported the following: "patient's right knee components were revised due to infection, all 4 components removed and replaced with a spacer.Initial op date was (b)(6) 2017 [sic] and it was of a primary component.No implants returned per hospital policy.All information available to me is included in this pi and attachment.".

• Brand Name: X3 TRIATHLON CS INSERT #7 11MM
• 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: 6858400
• Report Number: 0002249697-2017-02736
• Device Sequence Number: 496166
• Product Code: MBH
• UDI-Device Identifier: 07613327046038
• UDI-Public: 07613327046038
• 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: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/12/2017

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: 10/03/2020
• Device Catalogue Number: 5531G711
• Device Lot Number: LEP698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/12/2017
• 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: 63 YR
• Patient Weight: 130