MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 11MM; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5531G511
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	05/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices listed in this report: catalog (g): long description (g): lot/serial #: a 5520b500, triathlon prim cem fxd bplt #5 , ahy8j.A 5510f501, triathlon cr fem comp #5 l-cem, ahd3c.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Not returned.
Event or Problem Description
Sales rep reported patient was revised due to painful knee, hot bone.
Additional Manufacturer Narrative
An event regarding triathlon baseplate loosening involving triathlon insert was reported.Based on the information provided there is no indication or allegation that device reported in this investigation contributed to the event.The patient was revised for a loose baseplate.The insert is seated upon the baseplate and does not interact with bone and as such is not a contributor to loosening of the knee system.As part of revising the baseplate the insert would have had to be explanted.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Sales rep reported patient was revised due to painful knee, hot bone.Update: "the patient fell hard on her leg after her primary surgery and said it felt hot.The fall i'm sure played a part in the loosening of the tibial baseplate which is what led to surgery".

• Brand Name: X3 TRIATHLON CS INSERT #5 11MM
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6663529
• Report Number: 0002249697-2017-01988
• Device Sequence Number: 16637018
• Product Code: MBH
• UDI-Device Identifier: 07613327045864
• UDI-Public: 07613327045864
• 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: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2017

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: 07/07/2020
• Device Catalogue Number: 5531G511
• Device Lot Number: LEL981
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 08/24/2017
• 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: Other; Required Intervention
• Patient Age: 57 YR