MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #4 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-411-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	06/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reports pain and continued loss of mobility after revision surgery.Patient is inquiring if any parts were subject to a recall.
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.Device not returned.
Event or Problem Description
Patient reports pain and continued loss of mobility after revision surgery.Patient is inquiring if any parts were subject to a recall."updated based on medical review."this inquiry concerns a patient who developed arthrofibrosis following left total knee arthroplasty which required manipulation and eventually revision surgery.This report is for the pain and loss of mobility which has the event date 22 june 2021.
Additional Manufacturer Narrative
Reported event: an event regarding rom involving a triathlon insert was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical records by a clinical consultant indicated: this inquiry concerns a patient who developed arthrofibrosis following left total knee arthroplasty which required manipulation and eventually revision surgery.I can confirm that these events occurred since i was able to review the operation reports.The root cause of these events cannot be known with certainty.The causes of stiffness and arthrofibrosis following primary total knee arthroplasty are multifactorial including surgical technique and patient factors.These include placement of the implant, restoration of kinematics and stability, proper sizing, and positioning of the implants as well as postoperative compliance of the patient with a physical therapy program.In addition, there are some patients who are "scar formers" who are prone to arthrofibrosis.I would assign no causality to the implant itself.-device 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.Conclusion: a review of the provided medical records by a clinical consultant indicated: this inquiry concerns a patient who developed arthrofibrosis following left total knee arthroplasty which required manipulation and eventually revision surgery.I can confirm that these events occurred since i was able to review the operation reports.The root cause of these events cannot be known with certainty.The causes of stiffness and arthrofibrosis following primary total knee arthroplasty are multifactorial including surgical technique and patient factors.These include placement of the implant, restoration of kinematics and stability, proper sizing, and positioning of the implants as well as postoperative compliance of the patient with a physical therapy program.In addition, there are some patients who are "scar formers" who are prone to arthrofibrosis.I would assign no causality to the implant itself.It is noted that the patient is inquiring if the reported device is subject to a product recall.Based on the product details provided the reported device is not subject to product recall.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.

• Brand Name: X3 TRIATHLON CS INSERT #4 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 NJ NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14838350
• Report Number: 0002249697-2022-00927
• Device Sequence Number: 2367030
• Product Code: MBH
• UDI-Device Identifier: 07613327337433
• UDI-Public: 07613327337433
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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: 03/31/2025
• Device Model Number: 5531-G-411-E
• Device Catalogue Number: 5531-G-411-E
• Device Lot Number: LJX771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2020
• 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; Other
• Patient Age: 47 WK
• Patient Sex: Female
• Patient Weight: 69 KG