MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CR#7 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number 5530G709

Device Problems Material Distortion (2977); Naturally Worn (2988); Scratched Material (3020)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 08/15/2017

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 similar events for the lot referenced.There have been no other similar events for the sterile lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

Surgeon washed out a patient's infected knee, who had surgery in 2013.He swapped the poly out and reported it had severe posterior lateral wear.

Manufacturer Narrative

An event regarding infection and wear involving a triathlon insert was reported.The event regarding infection was not confirmed, however the event regarding wear was confirmed though material analysis.Device evaluation and results: burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.Damage consistent with edge loading from the femoral component was observed on the articulating-posterior surface of the insert.No material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation:not performed as no medical records were provided.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 or sterile lot referenced.The exact cause of the infection event could not be determined because insufficient information was provided.The material analysis report indicated: burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.Damage consistent with edge loading from the femoral component was observed on the articulating-posterior surface of the insert.No material or manufacturing defects were observed on the surfaces examined.Further information such as pre- and post-operative x-rays, operative reports, pathology reports as well as patient history and follow up notes are needed to complete the investigation for determining a root cause.After explanting the poly insert the surgeon noticed wear on the insert and returned it to stryker for investigation.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 Description

Surgeon washed out a patient's infected knee, who had surgery in 2013.He swapped the poly out and reported it had severe posterior lateral wear.

• Brand Name: X3 TRIATHLON INSERT CR#7 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6865212
• MDR Text Key: 86142589
• Report Number: 0002249697-2017-02771
• Device Sequence Number: 1
• Product Code: MBH
• 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: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2017
• Device Catalogue Number: 5530G709
• Device Lot Number: LDD592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2012
• 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): Hospitalization; Required Intervention