MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #1; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5520B100
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Triathlon was implanted on (b)(6) 2023 and the patient fell day one post op.Pt presented with pain (b)(6) 2023, plan to revise.
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.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.The following device were also listed in this report: device name#triathlon prim cem fxd bplt #1; cat# 5520b100; lot# rad2b it cannot be determined which, if any of these device may have caused or contributed to the patient's experience.
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: a review of medical records with a clinical consultant indicated "conclusion/assessment: no clinical history or medical records were provided for review outside of the pi report and a series of x-rays.No operative notes or other x-rays were provided for review.The x-rays provided showed failure of fixation of the primary tibial component.The implant is loose and collapsing into varus.Event confirmation: a loose tibia can be confirmed from the x-rays.A fall cannot be confirmed.A revision surgery cannot be confirmed (but would be expected).Root cause: a root cause of the tibial loosening cannot be confirmed without additional medical records.The reason for revision if confirmed would be tibial loosening and collapse.".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: a review of medical records with a clinical consultant indicated "conclusion/assessment: no clinical history or medical records were provided for review outside of the pi report and a series of x-rays.No operative notes or other x-rays were provided for review.The x-rays provided showed failure of fixation of the primary tibial component.The implant is loose and collapsing into varus.Event confirmation: a loose tibia can be confirmed from the x-rays.A fall cannot be confirmed.A revision surgery cannot be confirmed (but would be expected).Root cause: a root cause of the tibial loosening cannot be confirmed without additional medical records.The reason for revision if confirmed would be tibial loosening and collapse." 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
Triathlon was implanted on (b)(6) 2023 and the patient fell day one post op.Pt presented with pain september 24, plan to revise.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #1
• 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: 20457811
• Report Number: 0002249697-2024-01419
• Device Sequence Number: 21040487
• Product Code: MBH
• UDI-Device Identifier: 07613327041040
• UDI-Public: 07613327041040
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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 Catalogue Number: 5520B100
• Device Lot Number: RAD2B
• 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: 09/20/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2022
• 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: Hospitalization; Other
• Patient Age: 87 YR
• Patient Sex: Female