MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #2; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER

Catalog Number	5520B200
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: while performing a pressfit tibia, a cemented tibia was implanted.Sales rep noticed during the write up on the case that the incorrect implant was placed.Sales rep informed the surgeon as soon as it was noticed.The surgeon brought the patient back to the operating room and replaced the implant with a pressfit tibia.
Additional Manufacturer Narrative
Reported event: an event regarding incorrect selection - user error involving an triathlon baseplate was reported.The event was confirmed via review of the provided implant sheet.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: no medical records were received for review with a clinical consultant.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 refenced.Conclusions: it was reported that while performing a pressfit tibia, a cemented tibia was implanted.Sales rep noticed during the write up on the case that the incorrect implant was placed.Sales rep informed the surgeon as soon as it was noticed.The surgeon brought the patient back to the operating room and replaced the implant with a pressfit tibia.The reported event is considered to be the result of user error.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.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Corrected data: date of implant.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #2
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24441949
• Report Number: 0002249697-2026-00119
• Device Sequence Number: 10363994
• Product Code: JWH
• UDI-Device Identifier: 07613327041590
• UDI-Public: 07613327041590
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K242831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: 5520B200
• Device Lot Number: SH29N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2025
• 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: 46 YR
• Patient Sex: Female