MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI POST AUGMENT SZ4 5MM; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number 5543-A-400

Device Problems Mechanical Problem (1384); Loss of Osseointegration (2408)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 02/02/2018

Event Type  Injury  

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.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Not returned.

Event Description

As reported: "this is a study subject on the stryker sponsored study triathlon ts revision 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: TRI POST AUGMENT SZ4 5MM
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7652448
• MDR Text Key: 112836447
• Report Number: 0002249697-2018-02000
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327014686
• UDI-Public: 07613327014686
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 5543-A-400
• Device Lot Number: GXYZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 73