MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S2; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5536B200

Device Problem Migration (4003)

Patient Problems Injury (2348); Ambulation Difficulties (2544)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

It was reported that the patient's right knee was revised due to subsidence of the tibial baseplate.Intra-operatively, it was noted that the baseplate is fractured.The baseplate and liner were revised.No allegations against the revised liner were reported.

Manufacturer Narrative

An event regarding crack/fracture and subluxation involving a triathlon baseplate was reported.The event was confirmed by medical records.Method & results: device evaluation and results: visual inspection of images was performed and stated that - device seems to break with yellowish material on device surface.Functional, dimensional and material analysis not performed as device was not returned.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant stated that : there was varus collapse and subluxation of the tibial component as well as a baseplate fracture.The collapse and metal fracture necessitated a revision surgery.The fracture was likely due to fatigue as a result of micro motion associated with failure to in-growl medially.Obtaining the implant may provide insight into the mechanism of failure.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: it was reported that patient right knee was revised due to crack/fracture and subluxation.Visual inspection of images was performed and stated that - device seems to break with yellowish material on device surface.A review of the provided medical records and/or x-rays by a clinical consultant stated that : there was varus collapse and subluxation of the tibial component as well as a baseplate fracture.The collapse and metal fracture necessitated a revision surgery.The fracture was likely due to fatigue as a result of micro motion associated with failure to in-grow medially.Obtaining the implant may provide insight into the mechanism of failure.The exact cause of the event could not be determined because insufficient information was provided.Additional information including progress notes 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.

Event Description

It was reported that the patient's right knee was revised due to subsidence of the tibial baseplate.Intra-operatively, it was noted that the baseplate is fractured.The baseplate and liner were revised.No allegations against the revised liner were reported.

• Brand Name: TRITANIUM BPLATE TRIATHLON S2
• 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: 10323261
• MDR Text Key: 200397274
• Report Number: 0002249697-2020-01533
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 5536B200
• Device Lot Number: CTD14027
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention