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-611

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Injury (2348); Ambulation Difficulties (2544); No Information (3190)

Event Date 12/01/2010

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Email received from patient stating "i would like to know who to contact regarding issue i have had with an osteonics triathlon prosthetic knee joint i received [.]".

Event Description

Email received from patient stating "i would like to know who to contact regarding issue i have had with an osteonics triathlon prosthetic knee joint i received [.]" update: as per received 07-18-2018 op report: "arthroscopic synovectomy, removal of poly fragment".

Manufacturer Narrative

Reported event: an event regarding instability involving an triathlon insert was reported.The event was confirmed by medical review.Method & results: device evaluation and results: not performed as product remains implanted.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: "no examination of the explanted fragments of the polyethylene post and no operative report of the (b)(6) 2018 arthroscopy are available for review.Fracture of a ps tibial insert post usually results from impingement of the post on the femoral component as a result of soft tissue imbalance or rotational malposition of the femoral and/or tibial components.The post is not designed to maintain varus/valgus stability, but is rather to function as a cam to direct flexion as a substitute for the posterior cruciate ligament.Repeated impingement of the post on the femoral component would result in inevitable fatigue fracture not related to factors associated with manufacturing or material of the polyethylene insert." device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• 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: 8905768
• MDR Text Key: 154733806
• Report Number: 0002249697-2019-02890
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: 5532-G-611
• Device Lot Number: MJE2E9
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other