MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #6 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5510F601
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); Swelling/ Edema (4577)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via phone that; the patient had a total knee replacement in (b)(6) 2019.The whole thing has fallen apart and has to be revised next month.Pain, feels implant moving, swelling.Additional info.21-aug-2024: loosening.Update 09-sep-2024: per hospital, patient is being revised on (b)(6) 2024 to competitor product.
Additional Manufacturer Narrative
Reported event: an event regarding loosening 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 records by a clinical consultant indicated: "i can confirm that the patient had a primary cemented triathlon total knee arthroplasty with patella resurfacing using a cruciate retaining femur and a cs tibial insert, since i was able to review the operation report.I cannot confirm that the patient developed aseptic loosening since i had no access to x-rays showing the loose implants.However the patient did have a bone scan consistent with aseptic loosening.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of aseptic loosening of a cemented total knee arthroplasty for years following the index surgery on multifactorial including surgical technique, especially in achieving proper alignment, positioning, restoration of kinematics and cement technique.Patient factors include the patient's lifestyle, activity level, bone quality and bmi.With the information provided to me 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 events for the lot referenced.Conclusions: it was reported that the patient was to be revised due to loosening of the femoral component.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a primary cemented triathlon total knee arthroplasty with patella resurfacing using a cruciate retaining femur and a cs tibial insert, since i was able to review the operation report.I cannot confirm that the patient developed aseptic loosening since i had no access to x-rays showing the loose implants.However the patient did have a bone scan consistent with aseptic loosening.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of aseptic loosening of a cemented total knee arthroplasty for years following the index surgery on multifactorial including surgical technique, especially in achieving proper alignment, positioning, restoration of kinematics and cement technique.Patient factors include the patient's lifestyle, activity level, bone quality and bmi.With the information provided to me 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.".
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a triathlon femoral component was reported.The event was confirmed.Method & results: product evaluation and results: the femoral component was returned for evaluation.On the inferior surface there is evidence of bone cement with bone in-growth on the condyles.Damage consistent with explantation observed.Clinician review: a review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a primary cemented triathlon total knee arthroplasty with patella resurfacing using a cruciate retaining femur and a cs tibial insert, since i was able to review the operation report.I cannot confirm that the patient developed aseptic loosening since i had no access to x-rays showing the loose implants.However the patient did have a bone scan consistent with aseptic loosening.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of aseptic loosening of a cemented total knee arthroplasty for years following the index surgery on multifactorial including surgical technique, especially in achieving proper alignment, positioning, restoration of kinematics and cement technique.Patient factors include the patient's lifestyle, activity level, bone quality and bmi.With the information provided to me 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 events for the lot referenced.Conclusions: it was reported that the patient was to be revised due to loosening of the femoral component.The femoral component was returned for evaluation.On the inferior surface there is evidence of bone cement with bone in-growth on the condyles.Damage consistent with explantation observed.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a primary cemented triathlon total knee arthroplasty with patella resurfacing using a cruciate retaining femur and a cs tibial insert, since i was able to review the operation report.I cannot confirm that the patient developed aseptic loosening since i had no access to x-rays showing the loose implants.However the patient did have a bone scan consistent with aseptic loosening.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of aseptic loosening of a cemented total knee arthroplasty for years following the index surgery on multifactorial including surgical technique, especially in achieving proper alignment, positioning, restoration of kinematics and cement technique.Patient factors include the patient's lifestyle, activity level, bone quality and bmi.With the information provided to me i would not assign any causality to the implant itself.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 via phone that; the patient had a total knee replacement on (b)(6) 2019.The whole thing has fallen apart and has to be revised next month.Pain, feels implant moving, swelling.Additional info.21-aug-2024: loosening.Update 09-sep-2024: per hospital, patient is being revised on (b)(6) 2024 to competitor product.

• Brand Name: TRIATHLON CR FEM COMP #6 L-CEM
• 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: 20200292
• Report Number: 0002249697-2024-01269
• Device Sequence Number: 12639226
• Product Code: MBH
• UDI-Device Identifier: 07613327040319
• UDI-Public: 07613327040319
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: 02/28/2022
• Device Catalogue Number: 5510F601
• Device Lot Number: B777S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2017
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White