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); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	01/05/2024
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 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
Patient developed painful swollen knee.Surgeon believes due to asceptic loosening.Booked for revision of femoral component on (b)(6) 2024.Issue noticed: identified on a consult visit to surgeons rooms.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a triathlon femoral component was reported.The event was not confirmed.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: "confirmation of event: i can confirm that the patient had the primary total knee arthroplasty since i was able to review x-rays with the implant in place.I cannot confirm the revision since i have no supporting documentation such as office notes, operation note, or post revision x-rays.I cannot confirm loosening as i have no definitive evidence.Root cause analysis: assuming that the implant was loose and that it is the event in question, the root cause cannot be determined with certainty.The root causes of femoral loosening approximately five years after surgery are multifactorial including surgical technique, especially in the cement technique, and patient lifestyle, activity level and bmi.The possibility of other causes such as infection could also be considered.With the information provided i would not assign any causality to the implant itself." -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 event s for the lot referenced.Conclusions: it was reported that the patient was revised due to loosening of the femoral component.The exact cause of the event could not be determined because insufficient information was provided.A review of the provided medical records by a clinical consultant indicated: "confirmation of event: i can confirm that the patient had the primary total knee arthroplasty since i was able to review x-rays with the implant in place.I cannot confirm the revision since i have no supporting documentation such as office notes, operation note, or post revision x-rays.I cannot confirm loosening as i have no definitive evidence.Root cause analysis: assuming that the implant was loose and that it is the event in question, the root cause cannot be determined with certainty.The root causes of femoral loosening approximately five years after surgery are multifactorial including surgical technique, especially in the cement technique, and patient lifestyle, activity level and bmi.The possibility of other causes such as infection could also be considered.With the information provided i would not assign any causality to the implant itself." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.".
Event or Problem Description
Pt developed painful swollen knee.Surgeon believes due to asceptic loosening.Booked for revision of femoral component on (b)(6) 2024.Issue noticed: identified on a consult visit to surgeons rooms.

• 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-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19510042
• Report Number: 0002249697-2024-00865
• Device Sequence Number: 11617566
• Product Code: MBH
• UDI-Device Identifier: 07613327050400
• UDI-Public: 07613327050400
• 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: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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: 05/31/2024
• Device Catalogue Number: 5515-F-502
• Device Lot Number: D9U3OA
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2019
• 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: 62 YR
• Patient Sex: Male