MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #1 L-CEM; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5510F101
Medical Device Problem Codes	Malposition of Device (2616); Positioning Problem (3009)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Injury (2348)
Date of Event	11/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding baseplate loosening was reported, malposition of the triathlon femoral component was confirmed based on clinician review of the x-ray provided.Method & results: -product evaluation and results: damage was observed on the femoral component and baseplate, consistent with contact against each other.Delamination, burnishing, scratches and third-body indentations were observed on the insert condyles.These are common damage modes of uhmwpe.Debris was observed on the lateral condyle of the insert.Backside impression markings were observed on distal surface of the insert, consistent with contact against the baseplate.Eds showed the femoral component, baseplate and debris from the insert were all consistent with astm f75 alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: a clinician review of the provided medical records states the following; provided undated x-ray confirms subluxated femoral component posteriorly.Need operative reports, clinical reports, histopathology reports, office notes, serial x-rays and examination of the explanted components.- product history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: no other similar events were reported for the lot indicated.Conclusions: a clinician review of the provided medical records states the following; provided undated x-ray confirms subluxated femoral component posteriorly.Need operative reports, clinical reports, histopathology reports, office notes, serial x-rays and examination of the explanted components.The device was returned and material analysis was performed which confirmed damage was observed on the femoral component and baseplate, consistent with contact against each other.Delamination, burnishing, scratches and third-body indentations were observed on the insert condyles.These are common damage modes of uhmwpe.Debris was observed on the lateral condyle of the insert.Backside impression markings were observed on distal surface of the insert, consistent with contact against the baseplate.Eds showed the femoral component, baseplate and debris from the insert were all consistent with astm f75 alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, clinical reports, histopathology reports, office notes and serial x-rays are needed to fully investigate the event.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
It was reported that patient's left knee was revised.As reported by rep: ".Progressive pain, swelling, sense of unreliability.Ct and x-rays revealed tibial loosening.Soft tissue effusion, cell count (3,500) and synovasure worrisome for possible infection.Cultures negative to date".Update: a clinician review of the provided medical records states the following; provided undated x-ray confirms subluxated femoral component posteriorly.

• Brand Name: TRIATHLON CR FEM COMP #1 L-CEM
• 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: 8433739
• Report Number: 0002249697-2019-01368
• Device Sequence Number: 1663850
• Product Code: MBH
• UDI-Device Identifier: 07613327040203
• UDI-Public: 07613327040203
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2019

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: 12/31/2011
• Device Catalogue Number: 5510F101
• Device Lot Number: SCXEH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 03/19/2019
• 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: 75 YR
• Patient Weight: 62