MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #4R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5517F402
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
This report is for case 2 of 2.As reported by the chief nursing executive officer: twice now [stryker rep] has provided the physician with the wrong implant.The implant has been completely inserted and the physician has closed before [stryker rep] realized he provided the wrong product requiring us to open the patient a second time.Right tka; doctor was closing when noticed, patient never left room and femur was taken out and correct femur was put in.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding incorrect selection involving a triathlon femoral component was reported.The event was confirmed.Method and 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 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 during the patient's primary surgery, a cr femoral component was implanted instead of a ps.Revision surgery took place on the same day to have the incorrect femoral component replaced.The reported event was confirmed.The provided implant sheet was reviewed and confirmed that the reported device, a triathlon p/a cr beaded #4r, catalog: 5517f402, lot: h43hu was implanted in the patient's knee on (b)(6) 2025.The triathlon knee system surgical protocol, triath-sp-30_rev-1_29865 was reviewed and includes detailed step-by-step instructions on the preparation, sizing, trialling and placement of triathlon femoral components; a cr cemented femoral component is not compatible with a ps insert.This is considered to be the result of user error as no manufacturing-related product problem was found given the information provided.It is the responsibility of the surgical team to review the device label prior to implantation.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 P/A CR BEADED #4R
• 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 NA ; EI NA ; 61498200
• MDR Report Key: 21975601
• Report Number: 0002249697-2025-00481
• Device Sequence Number: 20660536
• Product Code: MBH
• UDI-Device Identifier: 07613327040944
• UDI-Public: 07613327040944
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: 5517F402
• Device Lot Number: H43HU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2025
• 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: 79 YR
• Patient Sex: Female