MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CS #3 10MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-310-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); Swelling/ Edema (4577)
Date of Event	08/29/2022
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 other 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.The following devices were also listed in this report: cat# 5536b300; tritanium bplate triathlon s3; lot# ctd74604.Cat# 5517f202; triathlon p/a cr beaded #2r; lot# nad7e.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient had pain and swelling in office note on (b)(6) 2022.Right knee was aspirated.Monitored progress and decided to do a closed manipulation on (b)(6) 2022.Patient's next appointment is on (b)(6) 2022.
Additional Manufacturer Narrative
Reported event: an event regarding pain involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: material analysis, visual, dimensional and functional inspections were not performed as the device remains implanted.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: 'this case concerns a patient who underwent a primary cementless total knee arthroplasty, developed arthrofibrosis, and then underwent manipulation.I am not sure why an inquiry was made about this case.Manipulation following primary total knee replacement is quite common and takes place in about 5% of patients.I can confirm that the patient underwent total knee arthroplasty and subsequent manipulation since i was able to review the operation reports.The causes of arthrofibrosis following primary total knee arthroplasty are multifactorial including surgical technique regarding implant sizing and kinematics and patient factors including compliance with postoperative instructions.There are also patients who are scar formers and are more prone to stiffness following arthroplasty.I would not assign any causality to the implant itself.' device history review: review of the device history records indicate the 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 stated the following comment: 'this case concerns a patient who underwent a primary cementless total knee arthroplasty, developed arthrofibrosis, and then underwent manipulation.I am not sure why an inquiry was made about this case.Manipulation following primary total knee replacement is quite common and takes place in about 5% of patients.I can confirm that the patient underwent total knee arthroplasty and subsequent manipulation since i was able to review the operation reports.The causes of arthrofibrosis following primary total knee arthroplasty are multifactorial including surgical technique regarding implant sizing and kinematics and patient factors including compliance with postoperative instructions.There are also patients who are scar formers and are more prone to stiffness following arthroplasty.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
Patient had pain and swelling in office note on (b)(6) 2022.Right knee was aspirated.Monitored progress and decided to do a closed manipulation on (b)(6) 2022.Patient's next appointment is on (b)(6) 2022.

• Brand Name: X3 TRIATHLON INSERT CS #3 10MM
• 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 15593012
• Report Number: 0002249697-2022-01479
• Device Sequence Number: 14032349
• Product Code: MBH
• UDI-Device Identifier: 07613327390544
• UDI-Public: 07613327390544
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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 Model Number: 5531-G-310-E
• Device Catalogue Number: 5531-G-310-E
• Device Lot Number: MD56P1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White