MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI PRESS-FIT STEM 17X150MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5566-S-017
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Unstable (1667); Loss of Osseointegration (2408); Malposition of Device (2616)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
It was reported that the patient's right knee was revised.Pre-operative diagnosis was failed total knee arthroplasty.Surgeon commented that he thought the femur was not cemented enough for proper fixation to occur.
Event or Problem Description
It was reported that the patient's right knee was revised.Pre-operative diagnosis was failed total knee arthroplasty.Surgeon commented that he thought the femur was not cemented enough for proper fixation to occur.
Additional Manufacturer Narrative
Reported event: an event regarding malposition involving a triathlon stem was reported.The event was confirmed through clinician review of the medical records provided.Method & results: product evaluation and results: the reported device was not returned however two photographs was provided for review.The photographs show a recently explanted femoral component with an augment attached.A triathlon stem is also attached.The photographs also show an explanted insert with damage to the post, most likely caused during explantation.Blood is also visible on the insert.Bone ingrowth is visible on the fixation side/underside of the femoral.Clinician review: a review of the provided medical records by a clinical consultant indicated: suboptimal cementation of the femoral condylar section of a triathlon ts femur in combination with undersizing and malalignment of a femoral stem extender due to incomplete cement removal during a previous revision have contributed to instability at the implant-bone interface leading to fixation failure requiring revision surgery.Product history review: indicated 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 lot referenced.Conclusion: an event regarding malposition involving a triathlon stem was reported.A review of the provided medical records by a clinical consultant indicated: suboptimal cementation of the femoral condylar section of a triathlon ts femur in combination with undersizing and malalignment of a femoral stem extender due to incomplete cement removal during a previous revision have contributed to instability at the implant-bone interface leading to fixation failure requiring revision surgery.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRI PRESS-FIT STEM 17X150MM
• 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: 8202605
• Report Number: 0002249697-2018-04155
• Device Sequence Number: 1656790
• Product Code: MBH
• UDI-Device Identifier: 07613327026900
• UDI-Public: 07613327026900
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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: 12/31/2013
• Device Catalogue Number: 5566-S-017
• Device Lot Number: M3S29E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 03/21/2019
• 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: 71 YR
• Patient Weight: 150