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
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0002249697-2023-00644
• Device Sequence Number: 20394298
• Product Code: MBH
• UDI-Device Identifier: 07613327041491
• UDI-Public: 07613327041491
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female