MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #0; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5520B000
Medical Device Problem Codes	Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Tka was performed on (b)(6) 2023.The tibial baseplate is sinking.The patient is currently walking with a cane and is concerned about the apparent bending of the knee and would like to have a revision.Revision surgery is scheduled for (b)(6) 2025 for the convenience of the physician.No further information is available from hcp at this time.
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.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding subsidence/malposition involving a triathlon baseplate was reported.The event was confirmed via medical review.Method & results: product evaluation and results: visual, dimensional, functional inspection and material analysis could not be performed as the device remains implanted.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: i have reviewed the documentation provided for pi including the product inquiry cover sheet, an event summary sheet, an ap and lateral xray of a cemented tha.Event description: tka was performed on (b)(6) 2023.The tibial baseplate is sinking.The patient is currently walking with a cane and is concerned about the apparent bending of the knee and would like to have a revision.Revision surgery is scheduled for (b)(6) 2025 for the convenience of the physician.No further information is available from hcp at this time.The ap and lateral tka x-rays show catastrophic failure of the tibial component with subsidence and severe angulation.Catastrophic failure of the tibial component with subsidence and severe angulation is confirmed.The root cause of this mechanical complication is not able to be determined from the limited information provided.Should further documentation become available i would be happy to further this investigation.Product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to pi including the product inquiry summary and an operative report, an ap x-ray of a pressfit ps tka, a photograph of the explanted tibial liner, and a review of the provided medical records by a clinical consultant stated the following comment: i have reviewed the documentation provided for pi including the product inquiry cover sheet, an event summary sheet, an ap and lateral xray of a cemented tha.Event description: tka was performed on (b)(6) 2023.The tibial baseplate is sinking.The patient is currently walking with a cane and is concerned about the apparent bending of the knee and would like to have a revision.Revision surgery is scheduled for (b)(6) 2025 for the convenience of the physician.No further information is available from hcp at this time.The ap and lateral tka x-rays show catastrophic failure of the tibial component with subsidence and severe angulation.Catastrophic failure of the tibial component with subsidence and severe angulation is confirmed.The root cause of this mechanical complication is not able to be determined from the limited information provided.Should further documentation become available i would be happy to further this investigation.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: TRIATHLON PRIM CEM FXD BPLT #0
• 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, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 22165363
• Report Number: 0002249697-2025-00613
• Device Sequence Number: 9209256
• Product Code: MBH
• UDI-Device Identifier: 07613327409208
• UDI-Public: 07613327409208
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: 5520B000
• Device Lot Number: PXD3N
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2022
• 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; Other; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female