MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G311

Device Problem Material Discolored (1170)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Injury (2348)

Event Date 06/14/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

The patient underwent primary tka surgery with triathlon in (b)(6) 2018.After the surgery, the patient claimed pain and limited range of motion.Treatment for synovitis was performed under arthroscopy.Then, open surgery was performed to resect the posterior synovial membrane on (b)(6) 2018 and the insert was also replaced.The removed inserted had turned yellow as a whole.

Manufacturer Narrative

An event regarding revision due to reduced range of motion(rom) involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection of the returned insert component observed pitting and yellowing is observed on the insert.Explantation damage is observed on the insert this also includes a hole which was drilled through the insert.The yellow discoloration observed on the insert is consistent with the absorption of synovial fluid by the device.Medical records received and evaluation: not performed as medical records were not received.Device history review: indicate all devices were manufactured and accepted into final stock on with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

The patient underwent primary tka surgery with triathron in april 2018.After the surgery, the patient claimed pain and limited range of motion.Treatment for synovitis was performed under arthroscopy.Then, open surgery was performed to resect the posterior synovial membrane on (b)(6) 2018 and the insert was also replaced.The removed inserted had turned yellow as a whole.

• Brand Name: X3 TRIATHLON CS INSERT #3 11MM
• 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: 7682074
• MDR Text Key: 113786460
• Report Number: 0002249697-2018-02150
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327045727
• UDI-Public: 07613327045727
• 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: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 5531G311
• Device Lot Number: LHA601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Date Manufacturer Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention