MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #4R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5517-F-402
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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 or Problem Description
Patient had bilateral staged index tka.Patient complains of instability and valgus deformity.Right lateral plateau collapse.Undergoes revision on (b)(6) 2021.All components exchanged except patella.
Additional Manufacturer Narrative
Reported event: an event regarding revision involving a triathlon femoral component was reported.The event was confirmed.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: [¿.]the following x-rays are provided:ap lateral and patella view of the knee preoperatively reveals advanced degenerative arthritis of the right knee complete collapse of the medial joint space.The lateral compartment and patella femoral joint also show degenerative change.Ap lateral and patella view of the right knee after primary surgery reveals a cementless triathlon implant.The tibial component appears undersized in relation to the size of the tibia with exposed medial plateau.The lateral view shows the tibial component to be in excessive flexion.Patella view shows satisfactory postop appearance.Ap lateral and patella view pre-revision reveals on ap view a significant dentate line surrounding the keel of the implant.Lateral view shows further flexion of the tibial component with radiolucency anteriorly beneath the tibial tray and a circumferential dentate line around the keel indicating loosening.The patella view is satisfactory[.]the diagnosis was mechanical complication of right total knee replacement and he revised the femur and tibia.The surgeon states that there was collapse of the lateral plateau but i cannot confirm this on the x-rays that i saw.He performed a revision of the femur and tibia.He states that he could not sublux the tibia anteriorly due to the femoral component being in place.Therefore, the femoral component was removed.No mention was made of whether the tibial implant was loose.It was removed and revision was carried out using stryker components.He elected to use a primary cr femur with a universal base plate, now number 4 with an 18 ¿ 100 mm press fit stem with a metaphyseal cone.He also used a 4 ¿ 13 cs polyethylene[.]conclusion of assessment:this inquiry reports failure of a cementless total knee arthroplasty due to tibial loosening.The index surgery was done in 2019 and it was revised in 2021.I can confirm that this event took place since to review the operation reports and the x-rays.Regarding the possible root cause of this event, i cannot determine it with certainty.However, in my opinion the tibial baseplate was undersized and in hyper flexion.In my experience these factors can lead to failure of fixation and subsequent displacement with loosening.I certify that i have completed the medical risk assessment to the best of my abilities as a healthcare professional and that my opinions reflect my personal and independent medical judgment and analysis.-product history review: review of the device history records indicate 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: the medical review stated " he states that he could not sublux the tibia anteriorly due to the femoral component being in place.Therefore, the femoral component was removed." there is no indication of any issue with the femoral component itself , as it was just removed to allow access to 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.
Event or Problem Description
Patient had bilateral staged index tka.Patient complains of instability and valgus deformity.Right lateral plateau collapse.Undergoes revision on (b)(6), 2021.All components exchanged except patella.

• Brand Name: TRIATHLON P/A CR BEADED #4R
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12795163
• Report Number: 0002249697-2021-01868
• Device Sequence Number: 12010524
• Product Code: MBH
• UDI-Device Identifier: 07613327040944
• UDI-Public: 07613327040944
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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 Expiration Date: 09/30/2023
• Device Model Number: 5517-F-402
• Device Catalogue Number: 5517F402
• Device Lot Number: EP36R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White