MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE5 BP; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5526B500
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Insufficient Information (4580)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: as per pss implant request: right knee instability and pain secondary to valgus alignment of tibial component.Pt has a triathlon uncemented right total knee replacement placed in (b)(6) 2011.She has a size 5 uncemented tibia, size 5 uncemented femur and 9mm cr polyethylene liner.The tibial component was placed in 5° of valgus malalignment and is the cause of persistent instability in the coronal plane and pain issues for which she is very unhappy.It is very well fixed and would be very difficult to remove.Femoral alignment is satisfactory) i would like a custom liner that is 9mm medially and is in 5° of varus to correct the malalignment.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding malposition involving a triathlon baseplate was reported.The event was confirmed via clinician review of provided medical records.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: i can confirm that the patient had a cementless cr triathlon total knee arthroplasty with residual valgus deformity in the upper tibia since i was able to view x-rays with the implant in place which demonstrates the deformity.Root cause analysis: the root cause of this event can be determined.In my opinion the root cause of this deformity is iatrogenic in that the tibia was cut in valgus rather than neutral alignment thereby resulting in an abnormal mechanical axis.A knee that is in valgus can result in instability and chronic pain from stretching of the medial collateral ligament upon ambulation.-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: it was reported as per pss implant request case: right knee instability and pain secondary to valgus alignment of tibial component.Pt has a triathlon uncemented right total knee replacement placed in 10/october/2011.She has a size 5 uncemented tibia, size 5 uncemented femur and 9mm cr polyethylene liner.The tibial component was placed in 5° of valgus malalignment and is the cause of persistent instability in the coronal plane and pain issues for which she is very unhappy.It is very well fixed and would be very difficult to remove.Femoral alignment is satisfactory) i would like a custom liner that is 9mm medially and is in 5° of varus to correct the malalignment.A review of the provided medical records by a clinical consultant indicated: i can confirm that the patient had a cementless cr triathlon total knee arthroplasty with residual valgus deformity in the upper tibia since i was able to view x-rays with the implant in place which demonstrates the deformity.The root cause of this event can be determined.In my opinion the root cause of this deformity is iatrogenic in that the tibia was cut in valgus rather than neutral alignment thereby resulting in an abnormal mechanical axis.A knee that is in valgus can result in instability and chronic pain from stretching of the medial collateral ligament upon ambulation.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PRIM BEAD PA SZE5 BP
• 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: 23346348
• Report Number: 0002249697-2025-01148
• Device Sequence Number: 21218526
• Product Code: MBH
• UDI-Device Identifier: 07613327041378
• UDI-Public: 07613327041378
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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 Expiration Date: 06/30/2016
• Device Catalogue Number: 5526B500
• Device Lot Number: S4LSD
• 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: 03/24/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2011
• 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: 82 YR
• Patient Sex: Female
• Patient Weight: 92 KG