MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE 4 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number 5531G409

Device Problems Material Discolored (1170); Material Deformation (2976); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348); Ambulation Difficulties (2544)

Event Date 10/15/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.The following devices were also listed in this report: triathlon prim bead pa sze4 bp; cat# 5526b400 ; lot# akx7t.Triathlon p/a cr beaded #4r; cat# 5517f402; lot# ade8s3.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Patient came in with pain and instability.

Manufacturer Narrative

An event regarding instability involving a triathlon insert was reported.Medical review and material analysis of the returned record confirms wear of the insert due to malposition of the baseplate and femoral component.Device evaluation and results: impression markings were observed on the distal surface of the insert, consistent with contact against the baseplate.Burnishing, scratching and third-body indentations were observed on the insert.Yellow discoloration was observed on the insert, consistent with absorption of synovial fluid.Explantation damage was observed on the insert.The medical review indicated femoral component malposition in posterior position plus excessive distal femoral bone resection in combination with baseplate malposition in excessive posterior slope of 11° has contributed to complex and global knee instability with pain symptoms requiring revision.Indicated all devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the reported lot.Conclusions: the material analysis concluded: the report concluded: burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of umwpe.Yellow discoloration was observed on the insert, consistent with absorption of synovial fluid.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.A review of the provided medical records by a clinical consultant indicated the medical review indicated femoral component malposition in posterior position plus excessive distal femoral bone resection in combination with baseplate malposition in excessive posterior slope of 11° has contributed to complex and global knee instability with pain symptoms requiring revision.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient came in with pain and instability.Update: based on the medical review - femoral component malposition in posterior position plus excessive distal femoral bone resection in combination with baseplate malposition in excessive posterior slope of 11° has contributed to complex and global knee instability with pain symptoms requiring revision.

• Brand Name: X3 TRIATHLON CS INS SIZE 4 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7270184
• MDR Text Key: 100053396
• Report Number: 0002249697-2018-00414
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327045802
• UDI-Public: 07613327045802
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 5531G409
• Device Lot Number: LES926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Date Manufacturer Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR