MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S3; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5536B300
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient fell several weeks post primary with subsequent issues with stability resulting in repeated falls leading to revision.Per revision op report: "surgical findings: instability, loose femur and tibial component with fibrous in-growth".
Additional Manufacturer Narrative
Reported event: an event regarding instability involving a triathlon baseplate was reported.The event was not 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 records with a clinical consultant indicated: "summary: this product inquiry concerns a female patient who was 68 years of age at the time of the event.Her bmi was 39.86 at the time of the original surgery.Her primary operation was performed on (b)(6) 2021.A cementless triathlon tritanium total knee arthroplasty with patella resurfacing was carried out.The patient reported a fall approximately seven weeks after her initial surgery.X-rays at that time revealed what the surgeon described as satisfactory appearance with no radiolucencies.The patient went on to develop pain and swelling from instability and loosening of at least the femoral component.X-rays prior to the revision revealed the patient underwent revision surgery on (b)(6) 2022 where the femoral component was found to be loose and the tibial component was removed as well.The patella component was satisfactory.Confirmation of event: i can confirm that patient had her primary and revision surgeries since i was able to review both of the operation reports.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of early pain, loosening and instability are multifactorial including initial surgical technique, restoration of kinematics, alignment, and position as well as sizing of the implants.With cementless implants, meticulous attention must be paid to the intimate fit of the implant to the host bone as well as proper positioning and sizing.In this particular case, the patient did sustain trauma in the early postoperative course which could contribute to post traumatic loosening.The x-rays that i reviewed that were prior to the revision showed a somewhat oversized femoral component, a tibial implant which was in my opinion flexed more than ideal, and gaps/resorption/radiolucency beneath the components.However these were about one year following her initial surgery.Other causes contributing could be the patient's bmi and activity level.With the information provided i would not assign any causality to the implant itself." -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: it was reported that the patient was revised due to instability.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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 fell several weeks post primary with subsequent issues with stability resulting in repeated falls leading to revision.Per revision op report: "surgical findings: instability, loose femur and tibial component with fibrous in-growth".

• Brand Name: TRITANIUM BPLATE TRIATHLON S3
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19403256
• Report Number: 0002249697-2024-00800
• Device Sequence Number: 7744405
• Product Code: MBH
• UDI-Device Identifier: 07613327041484
• UDI-Public: 07613327041484
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: 11/30/2025
• Device Catalogue Number: 5536B300
• Device Lot Number: CTD50860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2020
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 93 KG