MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A PS BEADED #5R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5516F502
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
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.The following devices were also listed in this report: triathlon ps x3 tibial insert; cat# 5532-g-616; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
As part of an investigator initiated study, a spreadsheet was provided indicating that the patient's right knee was revised due to instability.The femoral component and liner were revised.
Additional Manufacturer Narrative
Reported event: an event regarding instability involving a triathlon femoral component was reported.The event was confirmed via medical review.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 the provided medical records by a clinical consultant indicated: "i can confirm that the patient had both a primary right total knee arthroplasty as well as a revision right total knee arthroplasty performed by dr.Because i was able to review both operation reports and x-rays showing the implants in place.I can confirm that the patient developed in stability since this was documented in the clinical office notes.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of instability following cementless or cemented total knee arthroplasty are multifactorial, including surgical technique which requires equalizing and balancing the flexion, mid range and extension gaps.In this case, it appears that the procedure was performed satisfactorily.Patient factors also contribute, including lifestyle, activity level, and bmi.I would not assign any causality to the implant itself." -product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to instability.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had both a primary right total knee arthroplasty as well as a revision right total knee arthroplasty performed by dr.Because i was able to review both operation reports and x-rays showing the implants in place.I can confirm that the patient developed in stability since this was documented in the clinical office notes.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of instability following cementless or cemented total knee arthroplasty are multifactorial, including surgical technique which requires equalizing and balancing the flexion, mid range and extension gaps.In this case, it appears that the procedure was performed satisfactorily.Patient factors also contribute, including lifestyle, activity level, and bmi.I would not assign any causality to the implant itself." 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.

• Brand Name: TRIATHLON P/A PS BEADED #5R
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22434618
• Report Number: 0002249697-2025-00664
• Device Sequence Number: 3152501
• Product Code: MBH
• UDI-Device Identifier: 07613327040838
• UDI-Public: 07613327040838
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: 5516F502
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Male