MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5532-G-411

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Injury (2348); Fibrosis (3167)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

My husband had a knee replacement done in (b)(6) 2017 and for several months had swelling, instability and severe pain.Then he ended up having a revision done on (b)(6) 2018.Which there is still a lot of pain and swelling.This pi is for revision.

Manufacturer Narrative

Additional information: tab d, g and h-device information.An event regarding rom involving an triathlon insert was reported.The event was confirmed by medical review.Method & results: -product evaluation and results: not performed because the device was not returned for analysis.-clinician review: a review of the provided medical records by the consulting clinician indicated "patient underwent a cementless left tka on 03/16/2017.Initially the patent had a normal postoperative course but by 6 months postoperatively he developed an effusion and increased pain in the knee.Initially this was treated conservatively however his symptoms persisted and worsened and a workup including radiographs , bone scan and aspirations was performed seeking a possible infectious or mechanical cause for this problem.The infection workup proved to be negative and his symptoms persisted.On physical exam subtle varus/valgus instability was present and revision surgery was carried out on 02/15/2018.Fresh frozen soft tissue biopsy was obtained at the time of the revision and again no evidence for infection was seen.In addition to the biopsy the revision surgery comprised a thorough synovectomy and exchange to at thicker tibial insert in hopes of increasing knee stability.Post revision the patient continued to complain of severe pain and instability with the knee ¿kicking inwards¿ when he walked.The surgeon report the knee is stable on clinical exam and no evidence for infection, instability or mechanical complication existed.Exists.The patient had range of motion of -20 to 90 degrees.Further physical therapy with stretching and strengthening were recommended." -product history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: the event was confirmed by medical review.A review of the medical review revealed that "review of these records confirms pain and stiffness following primary and revision knee surgery most likely due to arthrofibrosis occurred however, the root cause cannot be determined as insufficient information was available.No evidence was for mechanical complication related to the implant was presented." no further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

My husband had a knee replacement done in march of 2017 and for several months had swelling, instability and severe pain.Then he ended up having a revision done on (b)(6)2018.Which there is still a lot of pain and swelling.This pi is for revision.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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: 7659717
• MDR Text Key: 113064057
• Report Number: 0002249697-2018-02056
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 5532-G-411
• Device Lot Number: RD6DP3
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 08/22/2018
• Supplement Dates FDA Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention