MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5536B600
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	10/27/2024
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 other similar events for the lot referenced.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
Revision surgery.Patient underwent tka on (b)(6) 2024.Deep cuts with mako, surgeon tried to implant a cementless femur although believes the cuts were to poor and ended up using a cemented femur.The medical intervention ended up being a revision of the tibia 2 days later due to the tibial baseplate not being fully seated on the bone.The complaint against the femur was the inaccuracy of the cuts leading to a gap between the implant and bone which led to the surgeon using a cemented implant, rather than a cementless.See attached two post op x-rays after the primary case showing the issues with the tibial baseplate which was the reason for the revision.
Event or Problem Description
Revision surgery.Patient underwent tka on (b)(6)2024.Deep cuts with mako, surgeon tried to implant a cementless femur although believes the cuts were to poor and ended up using a cemented femur.The medical intervention ended up being a revision of the tibia 2 days later due to the tibial baseplate not being fully seated on the bone.The complaint against the femur was the inaccuracy of the cuts leading to a gap between the implant and bone which led to the surgeon using a cemented implant, rather than a cementless.See attached two post op x-rays after the primary case showing the issues with the tibial baseplate which was the reason for the revision.
Additional Manufacturer Narrative
Reported event: an event regarding malposition 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 "x-rays show a hybrid tka with a cemented femur and a pressfit tka.The femur appears to be in an excessive valgus position while the tibial component is in a marked varus position with lucencies consistent with incomplete seating.Malposition of tka components is confirmed.The root cause of this mechanical complication can not be determined from the documentation provided.-product history review: product history review 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 "x-rays show a hybrid tka with a cemented femur and a pressfit tka.The femur appears to be in an excessive valgus position while the tibial component is in a marked varus position with lucencies consistent with incomplete seating.Malposition of tka components is confirmed.The root cause of this mechanical complication can not be determined from the documentation provided.It is likely the inaccuracy of the cuts leading to a gap between the implant and bone which led to the surgeon using a cemented implant, rather than a cementless.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: TRITANIUM BPLATE TRIATHLON S6
• 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: 20701321
• Report Number: 0002249697-2024-01575
• Device Sequence Number: 11691047
• Product Code: MBH
• UDI-Device Identifier: 07613327041514
• UDI-Public: 07613327041514
• 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: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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: 5536B600
• Device Lot Number: CTD122727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 11/16/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 120 KG