MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G311
Medical Device Problem Codes	Degraded (1153); Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Over time patient had less flexion and more pain.Explanted broken 3x11 cs poly.
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.
Additional Manufacturer Narrative
Reported event: an event regarding fracture & wear involving a triathlon insert was reported.The event was confirmed via inspection of the returned device.Method & results: product evaluation and results: visual inspection of the returned device indicated that the insert is worn.The damage present on the posterior portion was consistent with delamination and material loss.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.Two small fragment of the posterior edge has fractured.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.Clinician review: a review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a right total knee arthroplasty since i was able to review and x-ray with the implant in place.I can confirm that one of the radiograph submitted is consistent with complete loss of the polyethylene space on the medial side which could be due to polyethylene wear or fracture.I cannot confirm that the implant was fractured since i have no documentation except the narrative.I do not have an operation report or explanted photos.The root cause of fracture of a tibial x3 polyethylene insert in this case cannot be determined with certainty.Causes contributing to fracture of the polyethylene component include surgical technique in the way the implants are positioned and whether or not proper kinematics and ligament balancing is carried out.Causes also include patient factors such as lifestyle, activity level, and bmi.In this case the patient's bmi is 39.5 which is just slightly under designation of super obese.I have no information as to whether or not the patient developed any ligament laxity which could cause an overload situation.I would not necessarily assign causality to the implant itself unless under analysis some defect is found.With this patient's bmi i believe that is significantly contributing to the event." 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 revised due to fracture of the insert.Visual inspection of the returned device indicated that the insert is worn.The damage present on the posterior portion was consistent with delamination and material loss.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.Two small fragment of the posterior edge has fractured.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a right total knee arthroplasty since i was able to review and x-ray with the implant in place.I can confirm that one of the radiograph submitted is consistent with complete loss of the polyethylene space on the medial side which could be due to polyethylene wear or fracture.I cannot confirm that the implant was fractured since i have no documentation except the narrative.I do not have an operation report or explanted photos.The root cause of fracture of a tibial x3 polyethylene insert in this case cannot be determined with certainty.Causes contributing to fracture of the polyethylene component include surgical technique in the way the implants are positioned and whether or not proper kinematics and ligament balancing is carried out.Causes also include patient factors such as lifestyle, activity level, and bmi.In this case the patient's bmi is 39.5 which is just slightly under designation of super obese.I have no information as to whether or not the patient developed any ligament laxity which could cause an overload situation.I would not necessarily assign causality to the implant itself unless under analysis some defect is found.With this patient's bmi i believe that is significantly contributing to the event." 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
Over time patient had less flexion and more pain.Explanted broken 3x11 cs poly.

• Brand Name: X3 TRIATHLON CS INSERT #3 11MM
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19640956
• Report Number: 0002249697-2024-00938
• Device Sequence Number: 8793620
• Product Code: MBH
• UDI-Device Identifier: 07613327045734
• UDI-Public: 07613327045734
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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): 08/27/2024

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: 02/29/2024
• Device Catalogue Number: 5531G311
• Device Lot Number: LJA712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 06/30/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2019
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 104 KG