MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5520-B-400

Device Problems Inadequacy of Device Shape and/or Size (1583); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problem Injury (2348)

Event Date 10/10/2012

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Not returned.

Event Description

It was reported through the communication of an attorney that allegedly the patient was revised due to "failed right total knee arthroplasty (aseptic loosening of tibial component)".

Event Description

It was reported through the communication of an attorney that allegedly the patient was revised due to "failed right total knee arthroplasty (aseptic loosening of tibial component).".

Manufacturer Narrative

Reported event an event regarding revision due to loosening and subsidence involving a triathlon baseplate was reported.The event was confirmed through review of the provided medical records and x-rays by a clinical consultant.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: review of pre-revision x-rays demonstrate a cemented right tka.On the lateral view the tibial component is seen to be subsided in to the anterior aspect of the plateau and there is lucency between the posterior aspect of the tibial component and the cement.The component is in an anteriorly sloped position.Post revision xrays show a long stem cemented tibial component in anatomic position and appearing well fixed.Conclusion of assessment review of these records confirm the cause of this tkas failure is aseptic loosening of the tibia.Pre revision xrays show the tibial component is undersized.The lack of contact with supporting cortical bone is known to be a contributing factor for aseptic loosening of the tibia.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records and x-rays by a clinical consultant concluded: review of these records confirm the cause of this tkas failure is aseptic loosening of the tibia.Pre revision x-rays show the tibial component is undersized.The lack of contact with supporting cortical bone is known to be a contributing factor for aseptic loosening of the tibia.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• 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: 8634291
• MDR Text Key: 145902242
• Report Number: 0002249697-2019-02065
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050325
• UDI-Public: 07613327050325
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 5520-B-400
• Device Lot Number: BHDP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR