MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G509

Device Problems Difficult To Position (1467); Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicates the 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.

Event Description

Sales rep received a phone call from (b)(6) hospital (b)(6) 2017 - surgeon was unable to implant item ref 5531g509 in the operation (b)(6) 2017.After 4th trial to place the implant surgeon changed the implant to a new 5531g509 and was able to implant the this item without any issue.

Event Description

Sales rep received a phone call from (b)(6) on (b)(6) 2017 - surgeon was unable to implant item ref 5531g509 in the operation (b)(6) 2017.After 4th trial to place the implant surgeon changed the implant to a new 5531g509 and was able to implant the this item without any issue.

Manufacturer Narrative

Additional information: device evaluated by mfg.An event regarding a seating/locking issue involving a triathlon insert was reported.The event was confirmed by visual inspection.Method & results: -device evaluation and results: the size 5, 9mm insert component was returned.There is damage on the anterior edge of the device most likely caused during removal of the insert from the baseplate after attempted assembly.There is damage on the posterior aspect of the bearing surface of the device and on one of the posterior tabs.There is damage present on the anterior outside rim of the bearing surface.There are scratches evident on the inferior surface of the insert in the posterior compartment.These types of damage are indicative of an obstruction on the posterior aspect of the insert and on the retaining slot of the inferior surface which may have been the reason that the user failed to position the insert correctly on the baseplate.- medical records received and evaluation: not performed as no medical records were received.-device history review: dhr review for the reported lot was satisfactory.-complaint history review: chr review for the reported lot confirmed that there are no other similar events reported.Conclusions: based on the visual inspection of the returned component, the damage observed on the insert component is consistent with attempted seating of the insert onto the baseplate.The observed damage on the posterior aspect of the insert is indicative of an obstruction during attempted seating of the insert onto the baseplate which would have prevented successful assembly.No further investigation for this event is required at this time.

• Brand Name: X3 TRIATHLON CS INSERT #5 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7096489
• MDR Text Key: 94960599
• Report Number: 0002249697-2017-03510
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327045871
• UDI-Public: 07613327045871
• 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: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2022
• Device Catalogue Number: 5531G509
• Device Lot Number: LFP438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Date Manufacturer Received: 01/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 108