MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S4; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5536-B-400

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 05/19/2023

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding subsidence involving a triathlon baseplate was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this 70-year-old patient underwent a primary cementless total knee arthroplasty and then slightly more than four months later required revision for subsidence of the tibial baseplate.I can confirm that patient had a primary total knee arthroplasty and that the tibial baseplate subsided into varus.I cannot completely confirm that a revision occurred although i did see usage sheets with revision implants.The root cause of this event cannot be determined with certainty.However failure due to subsidence within four months following the initial surgery speaks of a failure of initial fixation which could be multifactorial in cause, including surgical technique factors, patient compliance and activity level as well as bmi.It would be highly unlikely that the implant itself contributed to the failure.In most cases the failure of fixation is due to factors including tibial preparation, bone quality and insertion technique.Proper sizing and positioning also plays a role.With the information provided i would not assign any causality to the implant itself." product history review: review of the device history records indicate the 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 lot referenced.Conclusions: it was reported that the patient's right knee was revised due to subsidence of the tibial baseplate.A review of the provided medical records by a clinical consultant indicated the following: "i can confirm that patient had a primary total knee arthroplasty and that the tibial baseplate subsided into varus.I cannot completely confirm that a revision occurred although i did see usage sheets with revision implants.The root cause of this event cannot be determined with certainty.However failure due to subsidence within four months following the initial surgery speaks of a failure of initial fixation which could be multifactorial in cause, including surgical technique factors, patient compliance and activity level as well as bmi.It would be highly unlikely that the implant itself contributed to the failure.In most cases the failure of fixation is due to factors including tibial preparation, bone quality and insertion technique.Proper sizing and positioning also plays a role.With the information provided i would not assign any causality to the implant itself." 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.H3 other text : device not returned.

Event Description

It was reported the patient's right knee was revised.As reported: "patient's tibia subsided so it was revised.Explanted were the tibial baseplate and insert.No other information available due to hospital policy.".

• Brand Name: TRITANIUM BPLATE TRIATHLON S4
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 17076270
• MDR Text Key: 316671862
• Report Number: 0002249697-2023-00644
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041491
• UDI-Public: 07613327041491
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2023

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 Model Number: 5536-B-400
• Device Catalogue Number: 5536B400
• Device Lot Number: CTD87655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female