MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 7; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5521-B-700
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/25/2025
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 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
As reported: "left total knee.The revision today was secondary to tibial loosening.No further information available from doctor or hospital." a ps knee was revised to a ts knee with stems and augments.Spoke to the rep.This surgeon does not do tibia-only revisions, so the entire construct was revised.Rep confirmed there are no allegations against the revised femur or insert.Patellar component was retained.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a triathlon baseplate 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: conclusion/assessment: no medical information, records, history, sequential x-rays or operative notes were provided for review.Based on the pi report, a single ap x-ray, and implant sheets, it appears that a revision surgery was performed for loosening of a tibial component.Rather than revising the tibia alone, the entire construct other than the patella were revised as the surgeon does not perform tibia only revisions.A ts revision was performed with augments on the femur and tibia, stems up and down, and a tibial cone.The outcome of the revision was not conveyed.Event confirmation: loosening of a tibial component can be confirmed based on an x-ray and the pi report.A revision can be confirmed by the pi report and an implant sheet.Root cause: the root cause of the revision surgery was tibial loosening.The root cause of the tibial loosening cannot be determined from the data provided.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 loosening.Loosening of a tibial component can be confirmed based on an x-ray and the pi report.A revision can be confirmed by the pi report and an implant sheet.The root cause of the revision surgery was tibial loosening.The root cause of the tibial loosening cannot be determined from the data provided.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: TRI TS BASEPLATE SIZE 7
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22048758
• Report Number: 0002249697-2025-00524
• Device Sequence Number: 15700877
• Product Code: MBH
• UDI-Device Identifier: 07613327026351
• UDI-Public: 07613327026351
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: 10/31/2023
• Device Catalogue Number: 5521-B-700
• Device Lot Number: DAY9OA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2018
• 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: 62 YR
• Patient Sex: Male