MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5515-F-502
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The following devices were also listed in this report: cat#: 5520b500; triathlon prim cem fxd bplt #5; lot#: blx9c it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported the patient's right knee was revised due to pain and suspected femoral loosening (surgeon had reported lucency anteriorly of the femur).Intra-operatively, it was noted the femur was difficult to remove.Surgeon's original plan was to revise the femur but decided to convert the entire ps knee to a ts knee with stems and augments.There were no allegations against the revised insert.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
An event regarding loosening involving a triathlon femoral component was reported.The event was not confirmed.Method & results -product evaluation and results: visual inspection of the photographs provided indicate that the femoral component is covered in biological matter.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: not performed as the device lot details were not provided.-complaint history review: not performed as the device lot details were not provided.Conclusions: visual inspection of the photographs provided indicate that the femoral component is covered in bone cement.Based on visual inspection, the loosening event cannot be confirmed as the cement appears well-adhered.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported the patient's right knee was revised due to pain and suspected femoral loosening (surgeon had reported lucency anteriorly of the femur).Intra-operatively, it was noted the femur was difficult to remove.Surgeon's original plan was to revise the femur, but decided to convert the entire ps knee to a ts knee with stems and augments.There were no allegations against the revised insert.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRIATHLON PS FEM COMPONENT CEMENTED
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20978986
• Report Number: 0002249697-2024-01768
• Device Sequence Number: 15565197
• Product Code: MBH
• UDI-Device Identifier: 07613327050400
• UDI-Public: 07613327050400
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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: 5515-F-502
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 04/29/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 111 KG