MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5521-B-600
Medical Device Problem Codes	Loss of Osseointegration (2408); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Inadequate Osseointegration (2646)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 7 years post-implant, the patient fell.X-rays appear to show that the tibial stem is no longer seated into the tibial baseplate.Surgeon would like to speak with a stryker engineer to discuss how this happened.At the time of report, the surgeon did not have a revision surgery scheduled.Rep confirmed there is no further information available at this time, but will report if the patient is revised.
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# tri press-fit stem 19x150mm; cat# 5566-s-019; lot# m9k49k.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 and disassociation 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 remains implanted.-clinician review: a review of the provided medical records by a clinical consultant indicated: conclusion/assessment: no medical records, pre or labeled postoperative x-rays were provided for review.Based on the pi report and the two unlabeled images, the patient, who clearly had a revision surgery, had a fall and when seen thereafter, by report, had failure of the tibial construct and an apparent fracture or dissociation of the stem from the baseplate.The condition of the tibial construct prior to the fall is unclear.The sequence of the provided images was unclear.If the first image was prior to the fall and the second is after the fall, then it is conceivable that the fall contributed to the failure.That said, the implant on the first image appears loose.Event confirmation: failure of a tibial revision component can be confirmed as can disassociation of the stem from the baseplate.A fall cannot be confirmed.Root cause: the root cause of the loosening, the tibial failure and stem disassociation cannot be ascertained without additional medical information.-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 7 years post-implant, the patient fell.X-rays appear to show that the tibial stem is no longer seated into the tibial baseplate.Surgeon would like to speak with a stryker engineer to discuss how this happened.At the time of report, the surgeon did not have a revision surgery scheduled.Rep confirmed there is no further information available at this time, but will report if the patient is revised.A review of the provided medical records by a clinical consultant concluded 'failure of a tibial revision component can be confirmed as can disassociation of the stem from the baseplate.A fall cannot be confirmed.Root cause: the root cause of the loosening, the tibial failure and stem disassociation cannot be ascertained without additional medical information.' 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, 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
No new information.

• Brand Name: TRI TS BASEPLATE SIZE 6
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21918532
• Report Number: 0002249697-2025-00443
• Device Sequence Number: 8714935
• Product Code: MBH
• UDI-Device Identifier: 07613327026337
• UDI-Public: 07613327026337
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: 07/31/2021
• Device Catalogue Number: 5521-B-600
• Device Lot Number: VED3A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2016
• 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: Other
• Patient Age: 87 YR
• Patient Sex: Male