MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 4 RIGHT; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5541-A-402
Medical Device Problem Codes	Mechanical Problem (1384); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	02/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding loosening involving a triathlon ts femoral augment was reported.The event was confirmed through clinician review of the revision operative notes provided.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: review of these records confirms the revision surgery of the tka femoral and tibial components occurred, however, the root cause cannot be determined as insufficient information was available.I am basing my confirmation of femoral and tibial component loosening primarily off of statements made in the surgeon¿s operative report.The surgeon does not specify the individual parts composing the tka components.When the augments, stems and femoral and/or tibial components are assembled intra-operatively they essentially become monolithic.By default, if one part of the monolithic composite is seen to be loose the entirety of the parts can be considered to be loose.Device history review: all 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 reported lot.Conclusion: the femoral and baseplate loosening was confirmed through clinician review of the revision operative notes provided.A review of the provided medical records by a clinical consultant stated the following: review of these records confirms the revision surgery of the tka femoral and tibial components occurred, however, the root cause cannot be determined as insufficient information was available.I am basing my confirmation of femoral and tibial component loosening primarily off of statements made in the surgeon¿s operative report.The surgeon does not specify the individual parts composing the tka components.When the augments, stems and femoral and/or tibial components are assembled intra-operatively they essentially become monolithic.By default, if one part of the monolithic composite is seen to be loose the entirety of the parts can be considered to be loose.Additional information including progress notes, pre-revision x-rays and evaluation of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
As reported: "this is a study subject on the (b)(6) study.The study coordinator sent in an adverse event form noting that the subject experienced femoral and tibial component loosening and underwent a revision on (b)(6) 2018".

• Brand Name: TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 4 RIGHT
• 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: 7652450
• Report Number: 0002249697-2018-02001
• Device Sequence Number: 11201169
• Product Code: MBH
• UDI-Device Identifier: 07613327015232
• UDI-Public: 07613327015232
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2018

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: 12/30/2013
• Device Catalogue Number: 5541-A-402
• Device Lot Number: YBID
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 06/29/2018
• 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; Other; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 73