MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS FEMUR SZ4 RIGHT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5512-F-402
Medical Device Problem Codes	Degraded (1153); Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); Metal Related Pathology (4530)
Date of Event	04/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event an event regarding crack/fracture involving a triathlon femoral component was reported.The event was 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 information by a clinical consultant indicated: adverse event identified: failure of a femora implant-stem construct at the threaded junction leading to complex revision surgery.Plus, multiple revision surgeries for femoral loosening and patellar mal-tracking without obvious or stated etiology.Hazards: failure of the femoral component-stem construct at the threaded junction.Conclusion of assessment: there were revision surgeries for femoral loosening and patellar mal-tracking but the work-up and etiology for these were not clear.The last revision was result of a failure of the femoral component-stem construct at the threaded junction.The likely cause of the failure was micromotion at the threaded junction led to wear and material fatigue.To determine the mode of failure additional materials would be required as well as evaluation of the explant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock on with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was revised that the patient's knee was revised due to a broken stem.Clinician review of provided records confirmed that failure of a femora implant-stem construct at the threaded junction leading to complex revision surgery.The likely cause of the failure was micro-motion at the threaded junction led to wear and material fatigue.However, the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device is needed to complete the investigation for determining root cause.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
It was reported that the patient's right knee was revised due to a broken stem.A 100mm x 15mm triathlon stem and size 4 femoral component were revised.Update per medical review: adverse event identified: failure of a femora implant-stem construct at the threaded junction leading to complex revision surgery.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture, wear/metallosis, and loosening involving a triathlon femoral component was reported.The events were confirmed via clinician review of the provided medical records.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: "conclusion/assessment: the records were not entirely complete, and no dated or sequential radiographs were provided for review.The patient had a primary knee performed and just over 6 months later had an arthroscopy for the it band and patellar tilt.The records gapped until 2012, when after having pain, the patient had a revision for a loose femur.She did well initially, but 1 ½ years later was seen for pain and instability and ultimately underwent an arthroscopy after an aspiration showed metal stained fluid.She then underwent revision of the femur, and it was found that she had broken the femoral stem at the junction with the threads.It was commented that the failure could represent corrosion.The revision became infected and she underwent a wash out and polyethylene exchange 6 months later.No records were provided for the later claims of another extensor mechanism disruption and revision and/or two stage revision thereafter.No additional materials were presented for review.Event confirmation: two arthroscopy procedures can be confirmed.A revision for a loose femur can be confirmed.A second revision for a loose femur and fracture of a femoral stem can be confirmed.The reason for the stem fracture cannot be confirmed.The two staged revision to competitor components cannot be confirmed.Root cause: the root cause for arthroscopy #1 was anterior knee pain, it band tendonitis and patellar tilt.The cause of the first femoral revision was loosening but a root cause cannot be attributed.The root cause of the second arthroscopy was pain and swelling and presence of metallic debris in aspirated fluid.The root cause of the metal stained fluid was motion at a fractured femoral stem.The root cause of the second revision was femoral loosening and a fractured femoral stem.The root cause of the stem fracture cannot be determined.The root cause of the last procedure, wash out and polyethylene revision, was infection.The root cause of the two stage revision which was not documented would presumed to be infection." 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 revised that the patient was revised due to a broken femoral stem as well as metallosis generating from the threaded junction of the stem and femoral component.Loosening of the femoral component was also reported.Clinician review of the provided medical records confirmed fracture of the femoral stem, wear/metallosis (metallic debris), and femoral loosening; however, the root cause could not be determined from the information provided.Further information such as return of the device is needed to complete the investigation for determining root cause.This patient has a long history of prior revisions and medical interventions in addition to a bmi in the morbidly obese range and elevated a1c.It was further reported that the patient had fallen prior to this revision.These patient factors may have contributed to the reported fracture and loosening events.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
It was reported that the patient's right knee was revised due to a broken stem.A 100mm x 15mm triathlon stem and size 4 femoral component were revised.Update per medical review:adverse event identified: failure of a femora implant-stem construct at the threaded junction leading to complex revision surgery.

• Brand Name: TRI TS FEMUR SZ4 RIGHT
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12127873
• Report Number: 0002249697-2021-01149
• Device Sequence Number: 19690101
• Product Code: MBH
• UDI-Device Identifier: 07613327026085
• UDI-Public: 07613327026085
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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: 08/31/2017
• Device Model Number: 5512-F-402
• Device Catalogue Number: 5512-F-402
• Device Lot Number: GLRR
• 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: 06/14/2021
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2012
• 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: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White