MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number 5531G513

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Failure to Align (2522)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2015

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Poly did not fully seat on the tibial tray.The surgeon felt the poly did not "click" into the tray as usual.The poly was removed and a new one was implanted in its place.The poly was 1mm above the tray.Even after re-impacting the poly it still did not fully seat.The second poly fully seated.Update as per sales rep 11/03/2015: the surgical delay was about two minutes for me to open another insert for him to re-implant.

Manufacturer Narrative

An event regarding a seating/locking issue involving a triathlon insert was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection of the returned component indicates that the types of damage observed on the insert are indicative of an obstruction on the posterior aspect of the insert and on the retention 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 provided.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, it appears that an obstruction on the posterior aspect of the insert and on the retention slot of the inferior surface may have been the reason that the user failed to position the insert correctly on the baseplate.A capa trend analysis was conducted for the reported failure mode and concluded that seating/locking difficulties may arise from user-related issues associated with the preparation of the joint space prior to the attempted seating and with the technique required to correctly introduce the insert component to the baseplate.No further investigation for this event is required at this time.

Event Description

Poly did not fully seat on the tibial tray.The surgeon felt the poly did not "click" into the tray as usual.The poly was removed and a new one was implanted in its place.The poly was 1mm above the tray.Even after re-impacting the poly it still did not fully seat.The second poly fully seated.Update as per sales rep 11/3/2015: the surgical delay was about two minutes for me to open another insert for him to re-implant.

• Brand Name: X3 TRIATHLON CS INSERT #5 13MM
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5226182
• MDR Text Key: 31473904
• Report Number: 0002249697-2015-03735
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 5531G513
• Device Lot Number: LDQ439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2014
• 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): Other
• Patient Age: 69 YR